Breast Disease Site

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MA39Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer
Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer

Complexity Level: 1

NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Planned

Chair: (Canada) Dr. Timothy J. Whelan, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495


Planned
MA36 (BIG 6-13)A Randomised, Double-Blind, Parallel group, Placebo-Controlled Multicenter Phase III Study to Assess the Efficacy and Safety of Olaparib versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy
A Randomised, Double-Blind, Parallel group, Placebo-Controlled Multicenter Phase III Study to Assess the Efficacy and Safety of Olaparib versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy

Complexity Level: 2

Eligibility: For inclusion in the study patients should fulfil the following criteria: Provision of informed consent prior to any study specific procedures, female or male patients must be greater than or equal to 18 years of age, histologically confirmed non-metastatic primary triple negative invasive adenocarcinoma of the breast that is at surgery: either axillary node-positive (any size) or node negative with primary tumour >2cm for patients who received adjuvant chemotherapy or showing evidence of non pCR for patients who received neoadjuvant chemotherapy. Patients must have a documented mutation in BRCA1 or BRCA2 predicted or suspected deleterious. Submission of (FFPE) tumour sample from the primary tumor is mandatory.

Objectives: The primary objective is to assess the effect of adjuvant treatment with olaparib on Invasive Disease Free Survival (IDFS. Secondary objectives aretTo assess the effect of adjuvant treatment with olaparib on overall survival (OS), to assess the effect of adjuvant treatment with olaparib on Distant Disease Free Survival (DDFS), to assess the effect of adjuvant treatment with olaparib on the incidence of new invasive breast primary cancer and/or new epithelial ovarian cancer, to assess the effect of olaparib on patient reported outcomes using the FACIT fatigue scale and EORTC QLQ-C30 QoL scale and to assess efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (gene sequencing and large rearrangement analysis).

NCT Registration ID (from clinicaltrials.gov): NCT02032823
Participation: Limited to invited centres; Site Selection Closed
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: July 20, 2015

Chair: (Canada) Dr. Andrea Eisen, Odette Cancer Centre, (416) 480-4617


Open to Accrual
MA37 (BIG 14-03)PALLAS: PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+)/ Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer
PALLAS: PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+)/ Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer

Complexity Level: 2

Eligibility: Premenopausal and postmenopausal women or men with Stage II (Stage IIA limited to a maximum of 1000 patients) or Stage III early invasive breast cancer. Patients with multicentric and/or multifocal and/or bilateral early invasive breast cancer whose histopathologically examined tumors all meet pathologic criteria for ER+ and/or PR+ and HER2-. Patients must have histologically confirmed hormone receptor positive (ER+ and/or PR+), HER2-, early invasive breast cancer. A formalin-fixed paraffin-embedded (FFPE) tumor tissue block must be transmitted to a central sample repository and confirmation of receipt must be available prior to randomization.

Objectives: To compare invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC). To compare the following endpoints: iDFS excluding second primary cancers of non-breast origin, distant recurrence-free survival (DRFS), locoregional recurrences-free survival (LRRFS), and overall survival (OS). To compare the safety of 2 years of palbociclib with adjuvant endocrine therapy versus adjuvant endocrine therapy alone.

NCT Registration ID (from clinicaltrials.gov): NCT02513394
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: January 25, 2017

Chair: (Canada) Dr. Julie Lemieux, CHA-Hopital Du St-Sacrement, (418) 649-5726


Open to Accrual
MAC18 (ALLIANCE A221405)POSITIVE: A Study Evaluating the Pregnancy Outcomes and Safety of Interrupting Endocrine Therapy for Young Women with Endocrine Responsive Breast Cancer who Desire Pregnancy
POSITIVE: A Study Evaluating the Pregnancy Outcomes and Safety of Interrupting Endocrine Therapy for Young Women with Endocrine Responsive Breast Cancer who Desire Pregnancy

Complexity Level: 3

Eligibility: Premenopausal women with endocrine responsive early breast cancer who received adjuvant endocrine therapy for 18 to 30 months, are between 18 and 42 years of age at enrollment, and wish to interrupt endocrine therapy to attempt pregnancy.

Objectives: Primary objective: To assess the risk of breast cancer relapse associated with temporary interruption of endocrine therapy (ET) to permit pregnancy. Secondary objective: To evaluate factors associated with pregnancy success after interruption of endocrine therapy.

NCT Registration ID (from clinicaltrials.gov): NCT02308085
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: March 16, 2016

Chair: (Canada) Dr. Ellen Warner, Odette Cancer Centre, (416) 480-4617


Open to Accrual
MAC19 (ALLIANCE A011202)A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1 -3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy
A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1 -3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy

Complexity Level: 2

Eligibility: Inclusion criteria: - Female or male >/= 17 years - T1-3, N1, M0 clinical stage - Axillary FNA or core biopsy documenting nodal disease - Invasive breast cancer - ER,PR, Her2 testing on breast core biopsy - Completed at least 6 cycles of neoadjuvant chemo - Anti Her 2 therapy if positive - Negative axilla on P/E after completion of NAC - Surgery
Objectives: Primary: To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of invasive breast cancer recurrence-free interval in patients with positive SLN(s) after completion of neoadjuvant chemotherapy.

NCT Registration ID (from clinicaltrials.gov): NCT01901094
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: December 17, 2015

Chair: (Canada) Dr. Steven Latosinsky, London Regional Cancer Program, (519) 685-8500 Ext. 58740


Open to Accrual
MAC20 (ALLIANCE A011401)Randomized Phase III Trial Evaluating the Role of Weight Loss In Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer
Randomized Phase III Trial Evaluating the Role of Weight Loss In Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer

Complexity Level: 3

Eligibility: Adult women with histologic diagnosis of invasive HER2 negative breast cancer within the past 12 months, who have a BMI >=27 kg/m^2 at the time of enrollment, who have completed all adjuvant or neoadjuvant chemotherapy and surgery, who do not have diabetes or comorbid conditions that would cause life expectancy of <4 years, and who have a self-reported ability to walk at least 2 blocks (at any pace).

Objectives: Primary Objective: Effect of supervised weight loss intervention plus health education materials vs. health education materials alone on invasive disease free survival in overweight and obese women. Secondary Objectives: Relationship between weight change and iDFS/clinical benefit; OS, distant DFS, weight/body composition, insulin resistance; Impact of supervised weight loss intervention on iDFS within subgroups of women (hormone receptor positive vs. negative breast cancer; premenopausal vs. menopausal); Quality of Life (QoL); physical activity and dietary intake; Patient reported outcomes (PRO).

NCT Registration ID (from clinicaltrials.gov): NCT02750826
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: November 11, 2016

Chair: (Canada) Dr. Vanessa Bernstein, BCCA - Vancouver Island Centre, (250) 519-5571


Open to Accrual
MAC21 (ALLIANCE A011502)A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for Node Positive HER2 Negative Breast Cancer: The ABC Trial
A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for Node Positive HER2 Negative Breast Cancer: The ABC Trial

Complexity Level: 3

Eligibility: Histologic documentation of women or men with node-positive, HER2 negative, anatomic Stage II or III breast carcinoma within one year of diagnosis and free of recurrence. Patients must be enrolled within 1 year after diagnosis. Patients must be > 18 and < 70 years of age. ECOG performance status 0-2. Any ER/PgR status allowed.

Objectives: Primary Objective: To compare the effect of aspirin (300 mg daily) versus placebo upon invasive disease free survival (iDFS) in early stage node-positive HER2 negative breast cancer patients. Secondary Objectives: To compare the effect of aspirin versus placebo in early stage node-positive HER2 negative breast cancer patients upon: a) Distant disease-free survival, b) Overall survival, c) Cardiovascular disease, To compare the toxicity of aspirin versus placebo in early stage node-positive HER2 negative breast cancer patients. To assess adherence to aspirin and placebo among early stage node-positive HER2 negative breast cancer patients. To bank tumor and germline deoxyribonucleic acid (DNA), plasma and urine collected at baseline and sequential plasma and urine collected 2 years later for future measurement of inflammatory markers. To determine if there are subgroups of participants characterized by lifestyle factors associates with greater inflammation

NCT Registration ID (from clinicaltrials.gov): NCT02927249
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: September 29, 2017

Chair: (Canada) Dr. Muhammad Salim, Allan Blair Cancer Centre, (306) 766-2691


Open to Accrual
MAC22 (ECOG-ACRIN EA1151)Tomosynthesis Mammographic Imaging Screening Trial (TMIST)
Tomosynthesis Mammographic Imaging Screening Trial (TMIST)

Complexity Level: 3

Eligibility: Patients must be women between the age 45 and 75 at the time of study entry. Women of childbearing potential must not be known to be pregnant or lactating Patients must be scheduled for, or have intent to schedule, a screening mammogram Patients must be able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol. Written informed consent No symptoms or signs of benign or malignant breast disease No screening mammogram within the last 11 months prior to date of randomization No previous personal history of breast cancer including ductal carcinoma in situ No breast enhancements

Objectives: To compare the proportions of participants in the Tomosynthesis (TM) and Digital Mammography (DM) study arms experiencing the occurrence of an advanced breast cancer at any time during a period of 4.5 years from randomization, including the period of active screening and a period of clinical follow-up after the last screen

NCT Registration ID (from clinicaltrials.gov): NCT03233191
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: October 13, 2017

Chair: (Canada) Dr. Martin Yaffe, Odette Cancer Centre, (416) 480-5715


Open to Accrual
MAX1 (QMUL LATTE)Long term Anastrozole vs Tamoxifen Treatment Effects (LATTE)
Long term Anastrozole vs Tamoxifen Treatment Effects (LATTE)

Complexity Level: 3

Eligibility: Patients must satisfy the following criteria to be eligible for entry into this study: patients randomised to one of the monotherapy arms in the ATAC Trial alive at 10 years follow-up

Objectives: Primary objectives The primary objectives of this study are to compare the long-term effects of tamoxifen (20 mg od) and anastrozole (1 mg od) which were given in the ATAC trial (and who have all now completed treatment + 5 years follow-up) as adjuvant therapy in terms of: Time to recurrence of breast cancer in the post 10 year period (defined as the earliest of local or distant recurrence, new primary breast cancer, or death) Death after recurrence Secondary objectives The secondary objectives of this study are to compare the long-term effects of tamoxifen (20 mg od) and anastrozole (1 mg od) which were given in the ATAC trial (and who have all now completed treatment) as adjuvant therapy in terms of: Time to distant recurrence Cancer-specific survival New breast primaries Other cancers Ischaemic cardiac and cerebrovascular events Hip (and other) fractures

NCT Registration ID (from clinicaltrials.gov): NCT01745289
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: June 21, 2016

Open to Accrual
I213A Randomized Phase II Study of Reolysin For Patients Receiving Standard Weekly Paclitaxel Therapy as Therapy For Advanced/Metastatic Breast Cancer
A Randomized Phase II Study of Reolysin For Patients Receiving Standard Weekly Paclitaxel Therapy as Therapy For Advanced/Metastatic Breast Cancer

Complexity Level: 2

Eligibility: Patients with histoligical/cytological diagnosis of metastatic breast cancer, that is advanced and/or metastatic, with no curative therapy and for which systemic therapy is indicated. Tumour block available. Patients must have measurable disease as defined by RECIST 1.1. Patients must have received at least one prior chemotherapy regimen for advanced or metastatic disease, unless they have relapsed within 6 months of completion of adjuvant chemotherapy or they have received taxane and/or anthracycline containing adjuvant chemotherapy. ECOG 0-2. No neuropathy > grade 1.

Objectives: Primary Objective: To evaluate the effect of reolysin in combination with standard paclitaxel chemotherapy on the progression free survival of patients with advanced or metastatic breast cancer Secondary Objectives: a) to determine the tolerability and toxicity of reolysin and paclitaxel when given in combination. b) to investigate additional potential measures of efficacy including: objective response rate, overall survival, CTC counts c) to explore potential molecular factors predictive of response by assessment of archival tumour tissue and CTCs, including EGFR and KRAS status.

NCT Registration ID (from clinicaltrials.gov): NCT01656538
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Closed to Accrual
Activation Date: July 30, 2012 Closing Date: April 20, 2016

Chair: (Canada) Dr. Susan Ellard, BCCA - Cancer Centre for the Southern Interior, (250) 712-3900 Ext. 686657, (Canada) Dr. Vanessa Bernstein, BCCA - Vancouver Island Centre, (250) 519-5571


Closed to Accrual
I229A Phase 1b Pharmacodynamic Study of Durvalumab (MEDI4736) in Patients with HER-2 Positive Metastatic Breast Cancer (MBC) Receiving Trastuzumab
A Phase 1b Pharmacodynamic Study of Durvalumab (MEDI4736) in Patients with HER-2 Positive Metastatic Breast Cancer (MBC) Receiving Trastuzumab

Complexity Level: 1

Eligibility: Patients with histologically and/or cytologically confirmed HER-2 positive metastatic breast cancer. Must have an available formalin fixed paraffin embedded tissue block from primary or metastatic tumour. Patients enrolled to the RP2D / expansion cohort must have accessible disease suitable for biopsy and have consented to biopsy prior to treatment and at the end of cycle 1 (paired biopsies are recommended in all patients). Patients must have measurable disease per RECIST 1.1 and adequate organ function. Age >=18 years. ECOG 0, 1, or 2. Must have had prior exposure to a taxane, trastuzumab and pertuzumab and preferably also prior exposure to TDM-1 (no limit to number of prior regimens). Prior surgery and radiation permitted provided adequate time has elapsed form last dose. No active or prior autoimmune or inflammatory disorders, or history of primary immunodeficiency. No live attenuated vaccination on treatment or within 30 days of either registration or last dose.

Objectives: PRIMARY - To determine the recommended phase II dose of durvalumab given to patients with advanced/recurrent HER-2 positive metastatic breast cancer (MBC) who are receiving treatment with trastuzumab. SECONDARY - (1) To describe the toxicities of durvalumab in patients receiving trastuzumab; (2) To evaluate the response rate and clinical benefit rate of durvalumab (measured by RECIST 1.1/Immune Response Criteria) in patients receiving trastuzumab; (3) To assess PD-L1 expression in paired biopsies pre and post treatment with durvalumab as a marker of response/benefit. EXPLORATORY - (1) To perform whole exome sequencing and RNAseq in paired biopsies (pre and post treatment) to explore biological correlates relative to PD-1/PD-L1 and trastuzumab and durvalumab exposure (minimum of 6 patients with paired biopsies); (2) To collect ctDNA as an exploratory marker; (3) To assess T cell and other immune cell subsets in paired biopsies pre and post treatment.

NCT Registration ID (from clinicaltrials.gov): NCT02649686
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: April 21, 2016 Closing Date: April 20, 2017

Chair: (Canada) Dr. Stephen Chia, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2752


Closed to Accrual
MA24 (BIG B016348)A Randomized Three-Arm Multi-Centre Comparison of 1 Year and 2 Years of Herceptin versus no Herceptin in Women With HER2-positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy
A Randomized Three-Arm Multi-Centre Comparison of 1 Year and 2 Years of Herceptin versus no Herceptin in Women With HER2-positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy

Complexity Level: 2

Eligibility: Women with primary breast cancer that over-expresses HER2 (determined by IHC 3+ or FISH positive) who have completed (neo-) adjuvant systemic chemotherapy and radiotherapy, if applicable.

Objectives: To compare disease-free survival (DFS) in patients with HER2 overexpressing breast cancer who have been randomized to Herceptin? for one year versus no Herceptin?. To compare DFS in patients with HER2 overexpressing breast cancer who have been randomized to Herceptin? for two years versus no Herceptin?.

NCT Registration ID (from clinicaltrials.gov): NCT00045032
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: February 07, 2002 Closing Date: April 05, 2004

Chair: (Canada) Dr. Karen Gelmon, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2032, (Canada) Dr. Kathleen I. Pritchard, Odette Cancer Centre, (416) 480-4616


Closed to Accrual
MA26 (RTOG 9804)Phase III Trial of Observation +/- Tamoxifen Vs. Rt +/- Tamoxifen For Good Risk Duct Carcinoma In-Situ (DCIS) of The Female Breast
Phase III Trial of Observation +/- Tamoxifen Vs. Rt +/- Tamoxifen For Good Risk Duct Carcinoma In-Situ (DCIS) of The Female Breast

Complexity Level: 2

Eligibility: Women > 26 years of age, with unicentric mammographically detected DCIS, < 2.5 cm in greatest dimension. Lesions must be classified as low or intermediate grade DCIS. Patients must be clinically node negative.

Objectives: In the defined good-risk group, assess the role of whole breast radiation +/- tamoxifen compared to wide excision to negative margins alone +/- tamoxifen, in decreasing or delaying the appearance of local failure, both invasive and in-situ, and preventing the need for mastectomy. Assess distant disease free survival, adopt a working pathology classification system for DCIS, establish a registry for patients with an epidemiological questionnaire, and to establish a tissue bank of patients who progress to local failure in the study breast.

NCT Registration ID (from clinicaltrials.gov): NCT00003857
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: January 09, 2002 Closing Date: July 14, 2006

Chair: (Canada) Dr. Eileen Rakovitch, Odette Cancer Centre, (416) 480-4806, (Canada) Dr. Timothy J. Whelan, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495


Closed to Accrual
MA28 (NCCTG N9831)Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment For Women With HER-2 Over-Expressing or Amplified Node Positive or High-Risk Node Negative Breast Cancer
Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment For Women With HER-2 Over-Expressing or Amplified Node Positive or High-Risk Node Negative Breast Cancer

Complexity Level: 2

Eligibility: Operable, histologically confirmed adenocarcinoma of the female breast and positive lymph nodes. Operable, histologically confirmed adenocarcinoma of the female breast and negative lymph nodes. =84 days from mastectomy or =84 days from axillary dissection or sentinel node detection if the patient's most extensive breast surgery was a breast sparing procedure. (This timing is per a decision by the Breast Intergroup.) TAM therapy =18 years of age with any menopausal status. Adequate bone marrow function. Adequate hepatic function Left ventricular ejection fraction (LVEF) within institutional normal range. If LVEF is > 75%, the investigator should consider performing a second review of the MUGA/echocardiogram or performing a repeat MUGA/echocardiogram prior to registration. Such re-reviews or repeat MUGA/echocardiogram are not permitted after registration

Objectives: To compare the combination AC followed by weekly paclitaxel with the sequential schedule of the combination of AC, weekly paclitaxel, and trastuzumab in terms of disease-free survival (DFS). To compare the combination of AC followed by weekly paclitaxel with the combination of AC followed by the combination of weekly paclitaxel and trastuzumab in terms of DFS. To compare the sequential schedule of AC, weekly paclitaxel, and trastuzumab with the combination of AC followed by the combination of weekly paclitaxel and trastuzumab in terms of DFS. To compare the cardiotoxicities of 1) AC followed by weekly paclitaxel, 2) AC followed by weekly paclitaxel followed by weekly trastuzumab, and 3) AC followed by weekly paclitaxel and trastuzumab followed by weekly trastuzumab To compare the combination of AC followed by weekly paclitaxel with the sequential schedule of the combination of AC, weekly paclitaxel, and trastuzumab in terms of overall survival (OS).

NCT Registration ID (from clinicaltrials.gov): NCT00005970
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual Closing Date: April 25, 2005

Chair: (Canada) Dr. Karen Gelmon, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2032


Closed to Accrual
MA31A Randomized, Open-Label, Phase III Study of Taxane Based Chemotherapy with Lapatinib or Trastuzumab as First-Line Therapy for Women with HER2/neu Positive Metastatic Breast Cancer
A Randomized, Open-Label, Phase III Study of Taxane Based Chemotherapy with Lapatinib or Trastuzumab as First-Line Therapy for Women with HER2/neu Positive Metastatic Breast Cancer

Complexity Level: 2

Eligibility: Women with documented evidence of HER2/neu positive breast cancer (by local or central laboratory testing) which is metastatic, and with no prior chemotherapy and/or anti-HER2/neu targeted therapy in the metastatic setting.

Objectives: Primary - Progression-Free Survival Secondary - Overall Survival - Time to CNS metastases at the time of progression - Incidence rates of CNS metastases at the time of progression - Overall objective response rate, time to response and duration of response - Clinical benefit response rate - Adverse event profile - Quality of Life (using the EORTC QLQ-C30 and a Trial Specific Checklist) - Clinical outcomes using biomarker changes in biological samples - Economic Evaluation: health utilities (using the EQ-5D questionnaire) and healthcare utilization

NCT Registration ID (from clinicaltrials.gov): NCT00667251
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Closed to Accrual
Activation Date: July 17, 2008 Closing Date: December 01, 2011

Chair: (Canada) Dr. Karen Gelmon, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2032


Closed to Accrual
MA32 (MA32)A Phase III Randomized Trial of Metformin versus Placebo on Recurrence and Survival in Early Stage Breast Cancer
A Phase III Randomized Trial of Metformin versus Placebo on Recurrence and Survival in Early Stage Breast Cancer

Complexity Level: 2

Eligibility: Breast cancer T1C-3, NO-3, M0

Objectives: Invasive disease free survival. Overall survival; distant disease-free survival; breast cancer free interval; invasive disease free survival in hormone receptor (ER and PgR) negative sub group; changes in body mass index; adverse events; other medical endpoints including a new diagnosis of diabetes mellitus or cardiovascular hospitalization or death (stroke, mycardial infarction); health related quality of life; correlative science outcomes; metabolic parameters and hospitalizations.

NCT Registration ID (from clinicaltrials.gov): NCT01101438
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: June 25, 2010 Closing Date: January 22, 2013

Chair: (UK) Dr. Daniel W. Rea, Institute of Cancer Research, (208) 722-4054, (Switzerland) Dr. Manuela Rabaglio, IBCSG Coordinating Centre, (44) 387-2550, (USA) Dr. Priya Rastogi, National Surgical Adjuvant Breast, (412) 330-4600, (Canada) Dr. Pamela J. Goodwin, Mount Sinai Hospital, (416) 586-8605, (UK) Prof. Judith Bliss, Institute of Cancer Research, (208) 722-4297, (USA) Dr. Dawn Hershman, Herbert Irving Cancer Center, (212) 305-1945, (USA) Dr. Ingrid Mayer, Vanderbilt University Medical Center, (615) 936-3524, (USA) Dr. Jennifer Ligibel, Dana-Farber Cancer Institute, (617) 632-3428


Closed to Accrual
MA32D (ALLIANCE A211201)Change In Mammographic Density with Metformin Use: A Companion Study to NCIC CTG Study MA.32
Change In Mammographic Density with Metformin Use: A Companion Study to NCIC CTG Study MA.32

Complexity Level: 3

Eligibility: Eligible patients must be either concurrently enrolling or previously enrolled to NCIC study MA.32. Eligible patients may be either pre- or post-menopausal. Patients must have hormone receptor-negative breast cancer. Patients must have breast density measurement as defined by either: >/= 25% density, or fibroglandular densities, or BIRAD-2 category or greater. Baseline digital mammograms taken within 12 months prior to registration to MA.32, with at least a craniocaudal (CC) view used for enrollment to NCIC MA.32 must be available for submission. If the patient has previously enrolled to MA.32 and one year has elapsed from baseline mammograms, one-year mammograms must also be available for submission. Women receiving endocrine therapy (e.g., tamoxifen, aromatase inhibitors) are not eligible. Contralateral unaffected breast in place (with no prior cancer or radiation, no implants and no plan for breast surgery on contralateral breast over the course of the study).

Objectives: To evaluate the change in percent mammographic density in contralateral (unaffected breast) from prior to the initiation of metformin or placebo treatment through one year of therapy in patients with hormone receptor negative breast cancer (i.e. not on endocrine therapy).

NCT Registration ID (from clinicaltrials.gov): NCT01666171
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: March 18, 2015 Closing Date: October 13, 2017

Chair: (Canada) Dr. Pamela J. Goodwin, Mount Sinai Hospital, (416) 586-8605, (Canada) Dr. Swati Kulkarni, Windsor Regional Cancer Centre, (519) 253-5353


Closed to Accrual
MA32F (NSABP MA32F)Biobehavioral Mechanisms of Fatigue in Patients Treated on NCIC CTG MA.32: A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival in Early Stage Breast Cancer (NCIC CTG MA.32 Ancillary Study led by the National Surgical Adjuvant Breast and Bowel Project)
Biobehavioral Mechanisms of Fatigue in Patients Treated on NCIC CTG MA.32: A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival in Early Stage Breast Cancer (NCIC CTG MA.32 Ancillary Study led by the National Surgical Adjuvant Breast and Bowel Project)

Complexity Level: 3

Eligibility: - The patient must have consented to participate and must have signed and dated an appropriate IRB-approved consent form that confirms to federal and institutional guidelines for the MA32F Study before being enrolled. - The patient must be female and reside in the United States or Canada. - The patient must be english speaking. - Patient must be eligible for randomization in the MA32 treatment trial. - The patient must not have started taking MA32 study therapy. - The patient must have completed primary breast radiation therapy at least two weeks prior to enrollment in MA32F. The patient is considered ineligible if: - MA32 therapy has been initiated. - Patient currently receiving radiation therapy or additional radiation therapy is planned for initiation after starting MA32 study therapy.

Objectives: - Determine the biological correlates of fatigue in breast cancer patients in the years following MA32 randomization and initiation of metformin or placebo. - Determine if specific SNPs in the promoter regions of IL-1 and IL-6 are associated with circulating markers of inflammation and fatigue in the years following MA32. - Determine which RNA gene expression pathways are associated with fatigue in metformin-treated patients and how do they relate to RNA gene expression pathways in untreated patients. - Determine the biological and behavorial predictors of fatigue in breast cancer patients in the years post-randomization. - Determine if metformin will be associated with reductions in inflammatory markers and corresponding decreases in fatigue.

NCT Registration ID (from clinicaltrials.gov): NCT01286233
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: October 28, 2011 Closing Date: January 25, 2013

Chair: (Canada) Dr. Julie Lemieux, CHA-Hopital Du St-Sacrement, (418) 649-5726, (USA) Dr. Patricia A. Ganz, University of California at Los Angeles (UCLA), (310) 206-3566


Closed to Accrual
MA33 (TROG 0701)A Randomised Phase III Study Of Radiation Doses And Fractionation Schedules For Ductal Carcinoma In Situ (DCIS) Of The Breast
A Randomised Phase III Study Of Radiation Doses And Fractionation Schedules For Ductal Carcinoma In Situ (DCIS) Of The Breast

Complexity Level: 2

Eligibility: Women with DCIS, radial margins >1 mm post-breast conserving therapy.

Objectives: Time of local recurrence Overall survival; disease-free survival; cosmetic outcome, acute and late toxicity; correlative studies.

NCT Registration ID (from clinicaltrials.gov): NCT00470236
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: April 29, 2009 Closing Date: June 20, 2014

Chair: (Canada) Dr. Ivo A. Olivotto, Tom Baker Cancer Centre, (403) 521-3105


Closed to Accrual
MA34 (BIG 4-11)A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as AdjuvantTherapy in Patients with Operable HER2-Positive Primary Breast Cancer
A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as AdjuvantTherapy in Patients with Operable HER2-Positive Primary Breast Cancer

Complexity Level: 2

Eligibility: Early breast cancer; HER2 positive centrally confirmed;, PS 0 -1, adequate bone marrow, liver, renal function; LVEF > 50%,blocks available for central collection. T1-4 any with N1 or T1c N0 or T1b NO if another high risk factor such as ER negative, age < 36 or Grade 3. The T1bN0 population will be limited to < 10% of the total population of 3806.

Objectives: Primary: Disease Free Survival Secondary: Overall Survival; EFS; QoL; A biologic correlate

NCT Registration ID (from clinicaltrials.gov): NCT01358877
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: April 05, 2012 Closing Date: June 28, 2013

Chair: (Canada) Dr. Susan Dent, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70167


Closed to Accrual
MA38 (MA38)Randomized Phase II Study Comparing Two Different Schedules of Palbociclib plus Second Line Endocrine Therapy in Women with Estrogen Receptor Positive, HER2 Negative Advanced/Metastatic Breast Cancer
Randomized Phase II Study Comparing Two Different Schedules of Palbociclib plus Second Line Endocrine Therapy in Women with Estrogen Receptor Positive, HER2 Negative Advanced/Metastatic Breast Cancer

Complexity Level: 2

Eligibility: Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy. Confirmed diagnosis of ER positive breast cancer Postmenopausal status or pre/perimenopausal women suitable for ovarian suppressive therapy Progressed on prior endocrine therapy for advanced disease or within 12 months of adjuvant endocrine therapy Measurable disease as per Response Evaluation Criterion in Solid Tumors [RECIST] or bone-only disease Eastern Cooperative Oncology Group [ECOG] 0-2 Adequate organ and marrow function

Objectives: Primary: Progression Free Survival Secondary: Adverse Events, Safety and Tolerability, Response Rate (in patients with measurable disease), Duration of Response, Clinical Benefit Rate, Overall Survival, Patient Reported Quality of Life using EORTC QLQC 30 and trial specific checklist, population PK/PD markers of drug effect in a subgroup of patients on both arms

NCT Registration ID (from clinicaltrials.gov): NCT02630693
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Closed to Accrual
Activation Date: December 16, 2015 Closing Date: February 10, 2017

Chair: (Australia) Dr. Andrew David Redfern, Fiona Stanley Hospital, (89) 224-0336, (Canada) Dr. Anil A. Joy, Cross Cancer Institute, (780) 432-8762


Closed to Accrual
MAC1 (CALGB 49907)A Randomized Trial of Adjuvant Chemotherapy With Standard Regimens, Cyclophosphamide, Methotrexate and Fluorouracil (CMF) or Doxorubicin and Cyclophosphamide - (AC), Versus Capecitabine in Women 65 Years and Older With Node Positive or Node-Negative Breast Cancer
A Randomized Trial of Adjuvant Chemotherapy With Standard Regimens, Cyclophosphamide, Methotrexate and Fluorouracil (CMF) or Doxorubicin and Cyclophosphamide - (AC), Versus Capecitabine in Women 65 Years and Older With Node Positive or Node-Negative Breast Cancer

Complexity Level: 2

Eligibility: Patients with operable, histologically confirmed adenocarcinoma of the female breast. TNM Stage must be T1-3, N1, M0, or T, N0, M0 if a primary lesion is > 3 cm. Patients must be 65 years of age or older, with a performance status of 0 - 2. Patients may have received up to 4 weeks of tamoxifen therapy for this malignancy and still be eligible. Patients who received tamoxifen or raloxifene for purposes of chemoprevention or for other indications (including previous breast cancer) are eligible. Tamoxifen or raloxifene therapy should be discontinued before the patient is enrolled on this study.

Objectives: To compare the effectiveness of standard chemotherapy regimens (CMF or AC) with single agent capecitabine with respect to disease-free survival in women 65 years of age and older with local and regional breast cancer. To compare the effectiveness of standard chemotherapy regimens with capecitabine with respect to overall survival. To determine the effects of each treatment regimen on quality of life and physical function. To assess the toxicity of each treatment regimen and to study the adherence to an oral chemotherapy regimen in older patients.

NCT Registration ID (from clinicaltrials.gov): NCT00024102
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: May 28, 2002 Closing Date: December 29, 2006

Chair: (Canada) Dr. Debjani Grenier, CancerCare Manitoba, St. Boniface General Hospital, (204) 235-3728


Closed to Accrual
MAC11 (SWOG S0221)A Phase III Trial of Continuous Schedule AC + G vs Q2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer.
A Phase III Trial of Continuous Schedule AC + G vs Q2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer.

Complexity Level: 2

Eligibility: Patients must be women or men with histological confirmed diagnosis of operable Stage I, II, or III invasive breast cancer with known Estrogen and Progesterone status. Patients with T4 tumours are not eligible.

Objectives: To compare the disease-free survival of patients with node-positive or high-risk node-negative breast cancer treated with 4 different schedules of adjuvant doxorubicin, cyclophosphamide, and paclitaxel. To comapre the overall survival, toxic effects and to correlate outcome with putative prognostic markers in patients treated with these regimens.

NCT Registration ID (from clinicaltrials.gov): NCT00070564
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: November 22, 2006 Closing Date: January 15, 2012

Chair: (Canada) Dr. Jean Latreille, Hopital Charles LeMoyne, (450) 466-5009


Closed to Accrual
MAC12 (ECOG PACCT-1)Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning IndividuaLized Options for Treatment: The TAILORx Trial
Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning IndividuaLized Options for Treatment: The TAILORx Trial

Complexity Level: 2

Eligibility: Patients with operable histologically confirmed adenocarcinoma of the female breast who have completed primary surgical treatment. ER and/or PR-positive Negative axillary nodes Tumor size 1.1-5.0cm (or 5mm-1.0cm) plus unfavorable histological features.

Objectives: Primary: To determine whether adjuvant hormonal therapy is not inferior to adjuvant chemohormonal. To create a tissue and specimen bank for patients enrolled in this trial. Secondary: To determine whether adjuvant hormonal therapy is sufficient treatment for women whose tumors meet established clinical guidelines. The primary study endpoint is disease-free survival; other co-primary endpoints include distant recurrence free interval, recurrence free interval, and overall survival.

NCT Registration ID (from clinicaltrials.gov): NCT00310180
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: September 21, 2006 Closing Date: October 06, 2010

Chair: (Canada) Dr. Kathleen I. Pritchard, Odette Cancer Centre, (416) 480-4616


Closed to Accrual
MAC13 (NCCTG N063D)Adjuvant, Lapatinib and/or Trastuzumab Treatment Optimisation Study A Randomised, Multi-Centre, Open-Label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients with HER2/ErbB2 Positive Primary Breast Cancer
Adjuvant, Lapatinib and/or Trastuzumab Treatment Optimisation Study A Randomised, Multi-Centre, Open-Label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients with HER2/ErbB2 Positive Primary Breast Cancer

Complexity Level: 2

Eligibility: The target population for this trial are patients with non-metastatic, operable and over expression/amplification of HER2 (3+ by IHC and/or FISH positive) primary breast cancer. They must have completed definitive surgery and received prior systemic (neo-) adjuvant anthracycline-based chemotherapy for primary breast cancer. In cases for which a taxane is indicated, it should be given concomitantly with the targeted therapy and after anthracycline-based chemotherapy. For patients in whom docetaxel is indicated, it must be given prior to targeted therapy. Patients should not have received any prior anti-HER therapy, which includes agents that target other members of the HER family of receptors, e.g. gefitinib (Iressa).

Objectives: Progression free survival

NCT Registration ID (from clinicaltrials.gov): NCT00490139
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: July 10, 2008 Closing Date: August 31, 2011

Chair: (Canada) Dr. Kathleen I. Pritchard, Odette Cancer Centre, (416) 480-4616


Closed to Accrual
MAC14 (ECOG-ACRIN 2108)A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer
A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer

Complexity Level: 2

Eligibility: 3.1 Registration (STEP 1) 3.1.1 Patients (male or female) must have an intact primary (not recurrent) invasive carcinoma of the breast. Biopsy confirmation of the primary tumor should be by needle biopsy (preferred); incisional surgical biopsy is allowed as long as there is residual palpable or imageable tumor in the breast. 3.1.2 Patients with synchronous contralateral breast cancer are excluded. 3.1.3 Patients should have at least one site of distant metastatic disease. If only a single metastatic lesion is present, biopsy is mandatory. See Section 3.1.6. 3.1.4 Radiology reports documenting status of disease prior to initiation of systemic therapy must be available. Scans must have been completed within 4 weeks prior to start of systemic therapy. 3.1.5 If patient has only one site of metastatic disease, this must be proven by biopsy and the pathology report confirming the diagnosis of primary breast cancer, as well as the metastatic site, must be available. Single metastatic lesion?

Objectives: Primary Objectives To evaluate whether early local therapy of intact primary disease in women with Stage IV breast cancer whose disease does not progress during initial optimal systemic therapy, will result in prolonged survival, compared to women who receive local therapy for palliation only

NCT Registration ID (from clinicaltrials.gov): NCT01242800
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: June 22, 2011 Closing Date: July 23, 2015

Closed to Accrual
MAC15 (SWOG S1007)A Phase III Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy Plus or Minus Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial Rx For Positive Node, Endocrine Responsive Breast Cancer.
A Phase III Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy Plus or Minus Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial Rx For Positive Node, Endocrine Responsive Breast Cancer.

Complexity Level: 3

Eligibility: Patients must have a histologically confirmed diagnosis of node positive (1-3 nodes) invasive breast carcinoma with positive estrogen and/or progesterone receptor status, and negative HER-2 status.

Objectives: Primary: Disease Free Survival Secondary: Overall survival; EFS; Economic; QoL; A biologic correlate

NCT Registration ID (from clinicaltrials.gov): NCT01272037
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: October 05, 2011 Closing Date: October 15, 2015

Chair: (Canada) Dr. Stephen Chia, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2752, (Canada) Dr. Sukhbinder Dhesy-Thind, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495 Ext. 64431


Closed to Accrual
MAC4 (IBCSG 24-02)A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women With Endocrine Responsive Breast Cancer
A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women With Endocrine Responsive Breast Cancer

Complexity Level: 2

Eligibility: Premenopausal women (estradiol (E2) levels in the premenopausal range) with histologically proven, resected breast cancer with ER and/or PR positive tumors who have received either no chemotherapy or remain premenopausal following completion of adjuvant and/or neoadjuvant chemotherapy.

Objectives: This trial will evaluate the worth of ovarian function suppression (achieved by either long-term use of GnRH analogue or surgical oophorectomy or ovarian irradiation) plus tamoxifen compared with tamoxifen alone for premenopausal women with steroid hormone receptor positive early invasive breast cancer who either receive no adjuvant chemotherapy or remain premenopausal following adjuvant and/or neoadjuvant chemotherapy. In addition, the worth of exemestane will be evaluated for this premenopausal patient population by comparing ovarian function suppression plus exemestane with tamoxifen alone and by comparing ovarian function suppression plus exemestane with ovarian function suppression plus tamoxifen.

NCT Registration ID (from clinicaltrials.gov): NCT00066690
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: October 07, 2003 Closing Date: April 30, 2010

Closed to Accrual
MAC5 (IBCSG 25-02)A Phase III Trial Evaluating the Role of Exemestane Plus GnRH Analogue as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer
A Phase III Trial Evaluating the Role of Exemestane Plus GnRH Analogue as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer

Complexity Level: 2

Eligibility: Premenopausal women with histologically proven, resected breast cancer with ER and/or PgR positive tumors. Patients should be randomized within 12 weeks after surgery prior to commencing any adjuvant systemic therapy.

Objectives: This trial will evaluate the worth of ovarian function suppression (achieved by long-term use of GnRH analogue) plus exemestane compared with GnRH analogue plus tamoxifen for premenopausal women with steroid hormone receptor positive early invasive breast cancer. Patients may either receive no chemotherapy or commence chemotherapy at the same time that GnRH analogue is initiated

NCT Registration ID (from clinicaltrials.gov): NCT00066703
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: October 07, 2003 Closing Date: March 11, 2011

Closed to Accrual
MAC7 (SWOG S0226)Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer
Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer

Complexity Level: 2

Eligibility: Post menopausal women with metastatic breast cancer

Objectives: To compare time to tumour progression in post-menopausal women with metastatic breast cancer treated with anastrozole versus anastrozole and fluvestrant.

NCT Registration ID (from clinicaltrials.gov): NCT00075764
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: January 23, 2006 Closing Date: July 01, 2009

Chair: (Canada) Dr. Ted A. Vandenberg, London Regional Cancer Program, (519) 685-8640


Closed to Accrual
MAC8 (NSABP B-37)A Randomized Clinical Trial of Adjuvant Chemotherapy for Radically Resected Loco-Regional Relapse of Breast Cancer.
A Randomized Clinical Trial of Adjuvant Chemotherapy for Radically Resected Loco-Regional Relapse of Breast Cancer.

Complexity Level: 2

Eligibility: Histologically proven local &/or regional recurrence of invasive breast cancer following primary treatment with mastectomy or breast conserving treatment. Surgical resection with radiotherapy (ro) or (ri). No evidence of distant mets. Measurement of hormone receptors in the recurrent tumour. Medically suitable for chemo of 3-6 months. Completed baseline QOL. Informed consent and agree to data and material transfer. Geographically accessible for f/u.

Objectives: Primary: To determine the efficacy of adjuvant chemotherapy, in terms of disease-free survival, in women with radically resected loco-regional relapsed breast cancer. Secondary: To determine systemic disease-free and overall survival; sites of recurrence, incidence of second (non-breast) malignancies, and causes of death without relapse of breast cancer; and to determine the quality of life of patients treated with this regimen.

NCT Registration ID (from clinicaltrials.gov): NCT00074152
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: February 11, 2005 Closing Date: November 30, 2007

Chair: (Canada) Dr. Mark Clemons, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70166


Closed to Accrual
MAC9 (SWOG S0307)Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer

Complexity Level: 2

Eligibility: Patients must be women with histologically confirmed primary invasive adenocarcinoma of the breast (Stage I, II, III) with no evidence of metastatic disease. Primary disease within the breast must be resected, either with mastectomy or breast sparing surgery. An axillary node evaluation should be performed per the standard of care specified at each institution.

Objectives: To compare disease-free survival and overall survival of women with resected primary stage I-III adenocarcinoma of the breast treated with adjuvant zoledronate vs clodronate vs ibandronate. To compare the distributions of sites of first disease recurrence, adverse events and to correlate parathyroid hormone related protein status and N-telopeptide levels at baseline with disease-free survival and sites of first recurrence in patients with these drugs.

NCT Registration ID (from clinicaltrials.gov): NCT00127205
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: July 24, 2006 Closing Date: February 01, 2010

Chair: (Canada) Dr. Mark Clemons, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70166


Closed to Accrual
MAP3A Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer
A Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer

Complexity Level: 3

Eligibility: Postmenopausal women at increased risk for the development of breast cancer are eligible for this study

Objectives: To determine if exemestane reduces the incidence of invasive breast cancer compared with placebo

NCT Registration ID (from clinicaltrials.gov): NCT00083174
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Closed to Accrual
Activation Date: February 11, 2004 Closing Date: March 23, 2010

Chair: (USA) Dr. Paul Goss, Massachusetts General Hospital Cancer Center, (617) 724-3118


Closed to Accrual
I129A Phase II Study of ZD0473 Given as a Short Infusion Every 3 Weeks to Patients With Advanced or Metastatic Breast Cancer
A Phase II Study of ZD0473 Given as a Short Infusion Every 3 Weeks to Patients With Advanced or Metastatic Breast Cancer

NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 14, 2000 Closing Date: March 02, 2001

Chair: (Canada) Dr. Karen Gelmon, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2032


Permanently Closed
I132A Phase II Study of Temozolomide Given in a 7 Days On, 7 Days Off Oral Schedule Every 4 Weeks to Patients with Advanced Breast Cancer
A Phase II Study of Temozolomide Given in a 7 Days On, 7 Days Off Oral Schedule Every 4 Weeks to Patients with Advanced Breast Cancer

Eligibility: Women with histologically documented advanced or metastatic breast cancer. Clinically and/or radiologically assessable disease. Unidimensional measurable disease. Prior adjuvant chemotherapy and/or up to two prior chemotherapy regimens for metastatic disease permitted.

Objectives: To assess the efficacy (measured by objective tumour response) of temozolomide when given in this schedule in this patient population. To determine the duration of response, time to progression and the toxic effects of temozolomide when administered in this fashion.

NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 01, 2000 Closing Date: September 26, 2001

Chair: (Canada) Dr. Maureen E. Trudeau, Odette Cancer Centre, (416) 480-5145


Permanently Closed
I163A Randomized Phase II Study of Two Different Schedules of RAD001C in Patients With Recurrent/Metastatic Breast Cancer
A Randomized Phase II Study of Two Different Schedules of RAD001C in Patients With Recurrent/Metastatic Breast Cancer

Eligibility: Patients with recurrent or metastatic breast cancer incurable by other means. Prior adjuvant as well as up to one prior regimen for recurrent/metastatic disease is permitted. Measurable disease. Paraffin embedded tumour sample available for study.

Objectives: To evaluate, in parallel, the anti-tumour efficacy of two oral treatment schedules of RAD001C. To assess the adverse events, time to progression and response duration of RAD001C in patients with recurrent/metastatic breast cancer.

NCT Registration ID (from clinicaltrials.gov): NCT00255788
Participation: Participation in this study is restricted to invited centres.
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 19, 2005 Closing Date: January 11, 2007

Chair: (Canada) Dr. Karen Gelmon, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2032, (Canada) Dr. Susan Ellard, BCCA - Cancer Centre for the Southern Interior, (250) 712-3900 Ext. 686657


Permanently Closed
I164A Phase II Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel in Advanced Breast Cancer
A Phase II Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel in Advanced Breast Cancer

Eligibility: Women with histologically documented breast cancer with metastatic or locally disease refractory to standard curative therapy. Prior adjuvant chemotherapy permissible; up to one prior chemotherapy regimen for metastatic disease and no prior taxane for metastatic disease. Prior hormonal therapy permitted, prior radiation therapy permitted if radiation involved <30% functioning bone marrow and >4 weeks. HER-2 positive patients may have had prior Herceptin treatment. ECOG 0,1,2. No brain metastases, no pre-existing neuropathy >= grade 2, no therapeutic anti-coagulation.

Objectives: To determine the efficacy, as measured by objective tumour response rate, of weekly OGX-011 and q 3 weekly docetaxel when given in combination to patients with advanced breast cancer. To assess the adverse events, tolerability, time to progression and overall survival in this population. To measure evidence of OGX-011 effect on serum clusterin levels.

NCT Registration ID (from clinicaltrials.gov): NCT00258375
Participation: CAKO, CALM, CAMN, CAMP, CANL, CAVA, CAVF, CAVK
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 27, 2005 Closing Date: September 29, 2006

Chair: (Canada) Dr. Stephen Chia, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2752


Permanently Closed
I18NCIC CTG Phase II Study of Flutamide in Breast
NCIC CTG Phase II Study of Flutamide in Breast

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 27, 1985 Closing Date: March 01, 1986

Permanently Closed
I19NCIC CTG Phase II Study of Menogaril in Breast
NCIC CTG Phase II Study of Menogaril in Breast

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 30, 1985 Closing Date: March 15, 1986

Permanently Closed
I197A Phase II Study of Foretinib in Patients with Estrogen Receptor (ER), Progesterone Receptor (PR), and Human Epidermal Growth Factor Receptor 2 (HER2) Negative, Recurrent/Metastatic Breast Cancer.
A Phase II Study of Foretinib in Patients with Estrogen Receptor (ER), Progesterone Receptor (PR), and Human Epidermal Growth Factor Receptor 2 (HER2) Negative, Recurrent/Metastatic Breast Cancer.

Complexity Level: 2

Eligibility: Advanced or recurrent/metastatic invasive breast cancer, that is ER, PR and HER2 negative.

Objectives: To determine the anti-tumour activity and toxicity of foretinib in this patient population.

NCT Registration ID (from clinicaltrials.gov): NCT01147484
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 25, 2010 Closing Date: August 02, 2013

Chair: (Canada) Dr. Daniel Rayson, QEII Health Sciences Centre, (902) 473-6106, (Canada) Dr. Sasha Lupichuk, Tom Baker Cancer Centre, (403) 521-3688


Permanently Closed
I198A Phase I/II Study of Foretinib in Combination with Lapatinib in Patients with Human Epidermal Growth Factor Receptor 2(HER2)Over-Expressing Metastatic Breast Cancer
A Phase I/II Study of Foretinib in Combination with Lapatinib in Patients with Human Epidermal Growth Factor Receptor 2(HER2)Over-Expressing Metastatic Breast Cancer

Complexity Level: 1

Eligibility: Histologically confirmed diagnosis of invasive breast cancer, that is HER2 positive as assessed by FISH or ICH 3+ staining (in accordance with ASCO guidelines) on the basis of local evaluation of HER2 status.

Objectives: To determine the recommended phase II dose (RP2D) of foretinib in combination with lapatinib, administered as a continuous daily oral dose, in patients with recurrent or metastatic HER2+ breast cancer. To evaluate the PK of lapatinib when given in combination with foretiib, preliminary evidence of anti-tumour activity, and to investigate the relationship between biomarkers and response.

NCT Registration ID (from clinicaltrials.gov): NCT01138384
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 03, 2010 Closing Date: March 05, 2013

Chair: (Canada) Dr. Stephen Chia, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2752


Permanently Closed
I35NCIC CTG Phase II Study of CMF/Lonidamine in Breast
NCIC CTG Phase II Study of CMF/Lonidamine in Breast

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 08, 1986 Closing Date: January 08, 1988

Permanently Closed
I45NCIC CTG Phase II Study of Oral Menogaril in Breast Cancer
NCIC CTG Phase II Study of Oral Menogaril in Breast Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 27, 1989 Closing Date: April 15, 1990

Permanently Closed
I4BNCIC CTG Phase II Study of Lonidamine in Breast Cancer
NCIC CTG Phase II Study of Lonidamine in Breast Cancer

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 01, 1983 Closing Date: May 13, 1985

Permanently Closed
I60NCIC CTG Phase II Study of 10-EDAM in Patients With Metastatic Breast Cancer
NCIC CTG Phase II Study of 10-EDAM in Patients With Metastatic Breast Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 29, 1990 Closing Date: September 17, 1991

Permanently Closed
I68NCIC CTG Phase II Study of Taxotere in Patients With Metastatic Breast Cancer
NCIC CTG Phase II Study of Taxotere in Patients With Metastatic Breast Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 01, 1992 Closing Date: June 30, 1993

Chair: (Canada) Dr. Maureen E. Trudeau, Odette Cancer Centre, (416) 480-5145


Permanently Closed
I73NCIC CTG Phase II Study of the Progesterone Antagonist Mifepristone (RU486) in Metastatic Breast Cancer
NCIC CTG Phase II Study of the Progesterone Antagonist Mifepristone (RU486) in Metastatic Breast Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 27, 1992 Closing Date: February 28, 1995

Permanently Closed
I93NCIC CTG Randomized Phase II Study of High-Dose Paclitaxel With or Without Amifostine in Patients With Metastatic Breast Cancer
NCIC CTG Randomized Phase II Study of High-Dose Paclitaxel With or Without Amifostine in Patients With Metastatic Breast Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 24, 1996 Closing Date: September 24, 1998

Chair: (Canada) Dr. Karen Gelmon, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2032


Permanently Closed
I97NCIC CTG Phase II Study of DPPE/Doxorubicin Chemotherapy in Metastatic Breast Cancer
NCIC CTG Phase II Study of DPPE/Doxorubicin Chemotherapy in Metastatic Breast Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 10, 1996 Closing Date: January 06, 1998

Chair: (Canada) Dr. Kong Eng Khoo, BCCA - Cancer Centre for the Southern Interior, (250) 712-3900 Ext. 683930


Permanently Closed
MA1NCIC Cooperative Clinical Trial of Tamoxifen versus Ovarian Ablation in the Treatment of Metastatic Breast Carcinoma in Premenopausal Women
NCIC Cooperative Clinical Trial of Tamoxifen versus Ovarian Ablation in the Treatment of Metastatic Breast Carcinoma in Premenopausal Women

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 06, 1981 Closing Date: May 30, 1983

Permanently Closed
MA10 (10921)A Multicentre Randomized Study of Dose-Intensive Chemotherapy as Primary Treatment in a Multimodality Approach for Locally Advanced/Inflammatory Breast Cancer (EORTC - NCIC CTG - SAKK Study)
A Multicentre Randomized Study of Dose-Intensive Chemotherapy as Primary Treatment in a Multimodality Approach for Locally Advanced/Inflammatory Breast Cancer (EORTC - NCIC CTG - SAKK Study)

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: August 13, 1993 Closing Date: April 02, 1996

Permanently Closed
MA11A Phase I Study of Escalating Epirubicin and Cyclophosphamide in Combination with 5-Fu Using Granulocyte Colony Stimulating Factor Support in Premenopausal Women With Axillary Node Positive Operable Breast Cancer
A Phase I Study of Escalating Epirubicin and Cyclophosphamide in Combination with 5-Fu Using Granulocyte Colony Stimulating Factor Support in Premenopausal Women With Axillary Node Positive Operable Breast Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 30, 1993 Closing Date: August 24, 1995

Chair: (Canada) Dr. Brian Findlay, Niagara Health System, (905) 684-7271 Ext. 43801


Permanently Closed
MA12Double-Blind Randomized Trial of Tamoxifen versus Placebo in Patients with Node Positive or High Risk Node Negative Breast Cancer Who Have Completed CMF, CEF, or AC Adjuvant Chemotherapy
Double-Blind Randomized Trial of Tamoxifen versus Placebo in Patients with Node Positive or High Risk Node Negative Breast Cancer Who Have Completed CMF, CEF, or AC Adjuvant Chemotherapy

NCT Registration ID (from clinicaltrials.gov): NCT00002542
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 20, 1993 Closing Date: April 28, 2000

Chair: (Canada) Dr. Vivien H. Bramwell, Tom Baker Cancer Centre, (403) 521-3707


Permanently Closed
MA13 (9082)A Randomized, Comparative Study of High Dose CPA/cDDP/BCNU and ABMS versus Standard Dose CPA/cDDP/BCNU as Consolidation to Adjuvant CAF for Patients with Operable Stage II or Stage II Breast Cancer Involving > 10 Axillary Lymph Nodes
A Randomized, Comparative Study of High Dose CPA/cDDP/BCNU and ABMS versus Standard Dose CPA/cDDP/BCNU as Consolidation to Adjuvant CAF for Patients with Operable Stage II or Stage II Breast Cancer Involving > 10 Axillary Lymph Nodes

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: June 10, 1993 Closing Date: May 29, 1998

Chair: (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 4567, (USA) Dr. William P. Peters, Karmanos Cancer Institute(313)


Permanently Closed
MA14A Randomized Trial of Antiestrogen Therapy versus Combined Antiestrogen and Octreotide Therapy in the Adjuvant Treatment of Breast Cancer in Post-Menopausal Women
A Randomized Trial of Antiestrogen Therapy versus Combined Antiestrogen and Octreotide Therapy in the Adjuvant Treatment of Breast Cancer in Post-Menopausal Women

NCT Registration ID (from clinicaltrials.gov): NCT00002864
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 24, 1996 Closing Date: July 21, 2000

Permanently Closed
MA15A Phase I/II Study of Docetaxel and Epirubicin as First Line Therapy for Metastatic Breast Cancer
A Phase I/II Study of Docetaxel and Epirubicin as First Line Therapy for Metastatic Breast Cancer

NCT Registration ID (from clinicaltrials.gov): NCT00002866
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 12, 1996 Closing Date: March 20, 2001

Chair: (Canada) Dr. Maureen E. Trudeau, Odette Cancer Centre, (416) 480-5145


Permanently Closed
MA16A Randomized Comparative Trial of High-Dose Chemotherapy and Autologous Stem Cell Support versus Standard Therapy Following Response to Anthracycline- or Taxane-Based Chemotherapy in Women With Metastatic Breast Cancer
A Randomized Comparative Trial of High-Dose Chemotherapy and Autologous Stem Cell Support versus Standard Therapy Following Response to Anthracycline- or Taxane-Based Chemotherapy in Women With Metastatic Breast Cancer

NCT Registration ID (from clinicaltrials.gov): NCT00003032
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 25, 1997 Closing Date: June 18, 2001

Chair: (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 4567


Permanently Closed
MA17 (MA17)A Phase III Randomized Double Blind Study of Letrozole versus Placebo in Women with Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen
A Phase III Randomized Double Blind Study of Letrozole versus Placebo in Women with Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen

Complexity Level: 2

Eligibility: Post-menopausal women who had receptor-positive breast cancer, or unknown receptor status breast cancer, and have completed at least five years of adjuvant tamoxifen therapy.

Objectives: To compare disease-free survival and overall survival. To compare incidence of contralateral breast cancer, and long-term clinical and laboratory safety. To evaluate overall quality of life.

NCT Registration ID (from clinicaltrials.gov): NCT00003140
Participation: Open to centres in participating cooperative groups.
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 24, 1998 Closing Date: September 04, 2002

Chair: (USA) Dr. Hyman B. Muss, Physicians Office Building, (919) 966-4431, (USA) Dr. Paul Goss, Massachusetts General Hospital Cancer Center, (617) 724-3118, (USA) Dr. Silvana Martino, John Wayne Cancer Institute, (310) 998-3961, (USA) Dr. Nicholas J. Robert, (703) 280-5390, (USA) Dr. James N. Ingle, NCCTG, Mayo Clinic, (507) 284-1887, (Belgium) Dr. Martine Piccart, Institut Jules Bordet, (2) 541-3111, (Switzerland) Dr. Monica Castiglione-Gertsch, SIAK/IBCSG Operations Office, (31) 389-9191


Permanently Closed
MA17BThe Influence of Letrozole on Bone Mineral Density in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen -- a Companion Study to MA.17
The Influence of Letrozole on Bone Mineral Density in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen -- a Companion Study to MA.17

Eligibility: Eligible women will have a BMD T score greater than or equal to 2.0 SD below the mean value of peak bone mass in young normal women. They must not have malabsorption syndrome, clinically relevant vitamin D deficiency, active hyper- or hypoparathyroidism, Paget?s disease, uncontrolled thyroid disease, Cushing?s disease, other pituitary diseases, or other bone diseases. Women must not have received previous treatment with anticonvulsants or anabolic steroids within the past 12 months, high doses of corticosteroids or sodium fluoride for an extended time, any drug including bisphosphonates for the prevention of osteoporosis within the past six months, or long term use of coumarins.

Objectives: To evaluate the effects of letrozole on bone mineral density in post-menopausal women treated with letrozole or placebo following at least five years of adjuvant tamoxifen therapy for breast cancer.

NCT Registration ID (from clinicaltrials.gov): no NCT
Participation: Limited to MA.17 participants
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 26, 2000 Closing Date: August 30, 2002

Chair: (USA) Dr. Paul Goss, Massachusetts General Hospital Cancer Center, (617) 724-3118


Permanently Closed
MA17LThe Influence of Letrozole on Serum Lipid Concentrations in Women with Primary Breast Cancer Who Have Completed Five Years of Adjuvant Tamoxifen -- A Companion Study to MA.17
The Influence of Letrozole on Serum Lipid Concentrations in Women with Primary Breast Cancer Who Have Completed Five Years of Adjuvant Tamoxifen -- A Companion Study to MA.17

Eligibility: MA.17 patients, who are non-hyperlipidemic and not taking lipid lowering agents.

Objectives: To evaluate the effects of letrozole on serum lipid parameters in post-menopausal women treated with letrozole or placebo following at least five years of adjuvant tamoxifen therapy for breast cancer.

NCT Registration ID (from clinicaltrials.gov): no NCT
Participation: Limited to MA.17 participants
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 09, 1999 Closing Date: May 02, 2002

Chair: (USA) Dr. Paul Goss, Massachusetts General Hospital Cancer Center, (617) 724-3118


Permanently Closed
MA17R (MA17R)A Double Blind Randomization to Letrozole or Placebo for Women Previously Diagnosed with Primary Breast Cancer Completing Five Years of Adjuvant Aromatase Inhibitor Either as Initial Therapy or After Tamoxifen (Including Those in the MA.17 Study)
A Double Blind Randomization to Letrozole or Placebo for Women Previously Diagnosed with Primary Breast Cancer Completing Five Years of Adjuvant Aromatase Inhibitor Either as Initial Therapy or After Tamoxifen (Including Those in the MA.17 Study)

Complexity Level: 2

Eligibility: Women completing around five years of aromatase inhibitor therapy, either as initial therapy or after tamoxifen, including those who received letrozole within the MA.17 study, are eligible for randomization to a further five years of letrozole or placebo. Eligible subjects must be free of recurrent breast cancer and have completed the five years of aromatase inhibitor therapy no more than 2 years prior to randomization. BMD measured by DEXA should be done within 4 weeks prior to randomization if not done within the previous 12 months, but the results do not affect eligibility.

Objectives: To compare the disease-free survival of subjects who receive 5 years of letrozole or placebo after having received around 5 years (4.5 - 6) of aromatase inhibitor therapy (letrozole, anastrozole, or exemestane) including those who received 5 years of adjuvant letrozole as part of the MA.17 trial. To evaluate the effect on overall (all cause specific) mortality. To evaluate the incidence of contralateral breast cancer. To evaluate the long term clinicial and laboratory safety of aromatase inhibitor therapy which includes 5 years of letrozole therapy. To evaluate overall quality of life (SF-36) and menopausal specific QOL (Menqol). To test the hypothesis that common genetic polymorphisms for genes encoding proteins involved in pharmacokinetic and/or pharmacodynamic pathways for the aromatase inhibitor letrozole contribute to individual variation in toxicity and efficacy of letrozole therapy.

NCT Registration ID (from clinicaltrials.gov): NCT00754845
Participation: Open to centres in participating cooperative groups.
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 14, 2004 Closing Date: May 08, 2009

Chair: (USA) Dr. Hyman B. Muss, Physicians Office Building, (919) 966-4431, (USA) Dr. James N. Ingle, NCCTG, Mayo Clinic, (507) 284-1887, (USA) Dr. Nicholas J. Robert, (703) 280-5390, (USA) Dr. Silvana Martino, John Wayne Cancer Institute, (310) 998-3961, (USA) Dr. Paul Goss, Massachusetts General Hospital Cancer Center, (617) 724-3118, (Belgium) Dr. Martine Piccart, Institut Jules Bordet, (2) 541-3111


Permanently Closed
MA19A Phase III Study of DPPE (BMS-217380-01) Combined With Doxorubicin versus Doxorubicin Alone in Metastatic/Recurrent Breast Cancer
A Phase III Study of DPPE (BMS-217380-01) Combined With Doxorubicin versus Doxorubicin Alone in Metastatic/Recurrent Breast Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 09, 1998 Closing Date: July 08, 1999

Permanently Closed
MA2Pilot Study of Sequential Hormono-Chemotherapy in Metastatic Breast Carcinoma
Pilot Study of Sequential Hormono-Chemotherapy in Metastatic Breast Carcinoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 04, 1981 Closing Date: August 20, 1982

Permanently Closed
MA20A Phase III Study of Regional Radiation Therapy in Early Breast Cancer
A Phase III Study of Regional Radiation Therapy in Early Breast Cancer

Complexity Level: 2

Eligibility: Pre or post menopausal women with node positive and high risk node-negative breast cancer treated by breast conserving therapy and currently accepted adjuvant chemotherapy and/or hormonal therapy.

Objectives: To determine if regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes) in addition to breast radiation prolongs survival in women with early breast cancer compared with breast radiation alone. To compare disease free survival, isolated local regional disease-free survival, and distant disease free survival. To evaluate toxicity. To evaluate quality of life. To determine the cosmetic outcome of these two treatment approaches.

NCT Registration ID (from clinicaltrials.gov): NCT00005957
Participation: Not limited.
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 14, 1999 Closing Date: February 02, 2007

Chair: (Australia) Dr. Boon Chua, Prince of Wales Hospital, (39) 656-1727, (USA) Dr. Julia White, Medical College of Wisconsin, (215) 955-6700, (USA) Dr. Lori Pierce, University of Michigan Medical School, (734) 764-9922, (Canada) Dr. Timothy J. Whelan, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495, (USA) Dr. Laura A. Vallow, NCCTG Operations Office, (904) 953-1040, (USA) Dr. David Parda, Allegheny General Hospital, (412) 359-3400


Permanently Closed
MA21 (MA21)A Phase III Adjuvant Trial of Sequenced EC + Filgrastim + Epoetin Alfa Followed by Paclitaxel Versus Sequenced AC Followed by Paclitaxel Versus CEF as Therapy for Premenopausal Women and Early Postmenopausal Women Who Have Had Potentially Curative Surgery for Node Positive or High Risk Node Negative Breast Cancer
A Phase III Adjuvant Trial of Sequenced EC + Filgrastim + Epoetin Alfa Followed by Paclitaxel Versus Sequenced AC Followed by Paclitaxel Versus CEF as Therapy for Premenopausal Women and Early Postmenopausal Women Who Have Had Potentially Curative Surgery for Node Positive or High Risk Node Negative Breast Cancer

Complexity Level: 2

Eligibility: Women with histologically confirmed adenocarcinoma of the breast treated with either total or partial mastectomy; node positive or high risk node negative; T0-T4, N0, N1, or N2, M0; ER status must be known; < 60 years of age; no prior chemotherapy, hormonal therapy, immunotherapy or radiotherapy for breast cancer; adequate blood counts; ECOG < 2; LVEF > institutional lower normal limit; no history of cardiac disease.

Objectives: To compare disease-free survival and overall survival among the three treatment arms. To compare rate of toxicities and quality of life among the three treatment arms.

NCT Registration ID (from clinicaltrials.gov): NCT00014222
Participation: Not Limited
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 04, 2000 Closing Date: April 29, 2005

Chair: (USA) Dr. Edith Perez, Mayo Clinic Jacksonville, (904) 953-7283, (USA) Dr. Kathy S. Albain, Loyola University Medical Center, (708) 327-3102, (Canada) Dr. Margot Burnell, Atlantic Health Sciences Corporation, (506) 648-6884, (Canada) Dr. Mark Levine, Henderson Hospital, (905) 527-4322 Ext. 42176, (USA) Dr. Hope Rugo, University of California, (415) 353-7618


Permanently Closed
MA22A Phase I/II Study of Increasing Doses of Epirubicin and Docetaxel Plus Pegfilgrastim for Locally Advanced Or Inflammatory Breast Cancer
A Phase I/II Study of Increasing Doses of Epirubicin and Docetaxel Plus Pegfilgrastim for Locally Advanced Or Inflammatory Breast Cancer

Complexity Level: 2

Eligibility: To determine MTD and recommended phase II dose of docetaxel and epirubicin with pegfilgrastim in a phase I dose escalation study as 1st line therapy. To evaluate toxicity of the combination at the recommended phase II dose. To evaluate response rate and duration of the combination as first-line therapy at the recommended phase II dose.

Objectives: Women with locally advanced or inflammatory breast cancer; no previous surgical systemic or radiation treatment for breast cancer other than biopsy for diagnosis; ECOG 0, 1, 2; adequate blood counts; LVEF > institutional lower normal limit; no history of cardiac disease.

NCT Registration ID (from clinicaltrials.gov): NCT00066443
Participation: Limited
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 25, 2003 Closing Date: June 08, 2009

Chair: (Canada) Dr. Maureen E. Trudeau, Odette Cancer Centre, (416) 480-5145


Permanently Closed
MA23 (10951)Randomized Phase II-III Study in First Line Hormonal Treatment for Metastatic Breast Cancer With Exemestane or Tamoxifen in Postmenopausal Patients
Randomized Phase II-III Study in First Line Hormonal Treatment for Metastatic Breast Cancer With Exemestane or Tamoxifen in Postmenopausal Patients

Eligibility: Postmenopausal patients with locally recurrent inoperable or metastatic carcinoma of the breast. Patients must have had histologically or cytologically confirmed adenocarcinoma of the breast at original diagnosis. At study entry the patient must have had metastatic progressive or locally recurrent inoperative breast cancer. Patients must have positive estrogen or progesterone receptor status at the time of original diagnosis or subsequently at a metastatic site.

Objectives: To determine if a hormonal therapy with exemestane is superior in terms of progression-free survival to tamoxifen in first line advanced breast cancer. To further document the safety profile of exemestane and to compare overall survival between the treatment arms.

NCT Registration ID (from clinicaltrials.gov): NCT00002777
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: August 08, 2001 Closing Date: September 20, 2002

Permanently Closed
MA25 (S9927)Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary nodes
Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary nodes

Eligibility: Women with histologically confirmed adenocarcinoma of the breast, with the primary tumour < 5 cm and 1-3 postive axillary nodes (pathologic T1-2, pathologic N1). Patients with apocrine, adenocystic, or squamous carcinomas or sarcomas of the breast or bilateral breast cancer are not eligible.

Objectives: To compare overall and disease-free survival in pre- and post-menopausal women with Stage II breast cancer and 1 ? 3 positive nodes treated with or without radiation therapy following mastectomy and adjuvant chemotherapy. To assess local-regional control for this cohort of patients. To assess the potential toxicities of radiotherapy delivered using CT-directed treatment in this cohort of patients.

NCT Registration ID (from clinicaltrials.gov): NCT00005983
Participation: Limited to centres with current CPA/FWA #
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: November 22, 2001 Closing Date: June 15, 2003

Chair: (Canada) Dr. David R. McCready, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-6510, (Canada) Dr. Timothy J. Whelan, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495


Permanently Closed
MA27 (MA27)A Randomized Phase III Trial of Exemestane Versus Anastrozole in Postmenopausal Women with Receptor Positive Primary Breast Cancer
A Randomized Phase III Trial of Exemestane Versus Anastrozole in Postmenopausal Women with Receptor Positive Primary Breast Cancer

Eligibility: Post-menopausal women who have histologically or cytologically confirmed, receptor-positive, adequately excised, primary breast cancer are eligible for this trial. Adjuvant chemotherapy and radiation are allowable. Chemotherapy must be completed before randomization. Radiotherapy may be given prior to or concurrently with protocol therapy.

Objectives: To compare event free survival (EFS) between women treated with Exemestane or Anastrozole as adjuvant therapy. To compare the incidence of contralateral breast cancer, the time to distant recurrence, survival & safety among treatment groups.

NCT Registration ID (from clinicaltrials.gov): NCT00066573
Participation: NCIC CTG, CTSU sites, IBCSG
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 02, 2003 Closing Date: July 31, 2008

Chair: (USA) Dr. G. Thomas Budd, Cleveland Clinic Foundation, Desk R35, (216) 444-6480, (USA) Dr. James N. Ingle, NCCTG, Mayo Clinic, (507) 284-1887, (USA) Dr. Paul Goss, Massachusetts General Hospital Cancer Center, (617) 724-3118, (USA) Dr. Matthew J. Ellis, Washington University School of Medicine, (314) 362-8903, (USA) Dr. George W. Sledge, Indiana Cancer Pavilion, RT-473, (317) 278-7576


Permanently Closed
MA27B (MA.27B)The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density in Postmenopausal Women with Primary Breast Cancer - A Companion Study to MA.27
The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density in Postmenopausal Women with Primary Breast Cancer - A Companion Study to MA.27

Eligibility: MA.27 patients who have a bone mineral density measurement (using DEXA: dual energy x-ray absorptiometry) done within 12 weeks prior to randomization to the MA.27 core protocol may participate in the companion protocol. In order to be eligible patients must not have malabsorption syndrome, clinically relevant vitamin D deficiency, active hyper- or hypoparathyroidism, Paget's disease, uncontrolled thyroid disease, Cushing's disease, other pituitary diseases, or other bone diseases. Patients must not have received previous treatment with anticonvulsants or anabolic steroids within the past 12 months, high doses of corticosteroids or sodium fluoride for an extended time or be on long term treatment with coumarins

Objectives: The primary objective is to examine whether there is a clinically relevant difference in impact on BMD between the steroidal (exemestane) and the non-steroidal (anastrozole) agents at 2 years

NCT Registration ID (from clinicaltrials.gov): NCT00354302
Participation: Limited to MA.27 participants
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 24, 2006 Closing Date: May 30, 2008

Chair: (USA) Dr. Paul Goss, Massachusetts General Hospital Cancer Center, (617) 724-3118


Permanently Closed
MA27D (N0434)The Association of Breast Density Changes, Plasma Hormone Changes, and Breast Cancer Recurrence: A Companion Study to NCIC CTG MA.27
The Association of Breast Density Changes, Plasma Hormone Changes, and Breast Cancer Recurrence: A Companion Study to NCIC CTG MA.27

Eligibility: MA.27 patients with one intact non-cancerous breast with no hormone, SERM or GnRHA therapy within the past 12 months and no hormone, SERM or GnRHA therapy within 6 months prior to the pre-registration mammogram are eligible for this companion study to MA.27

Objectives: To assess the change in percent breast density and change in dense area in response to aromatase inhibitor therapy, whether these changes correlate with changes in plasma hormones and whether these changes, over time, are associated with recurrence of breast cancer

NCT Registration ID (from clinicaltrials.gov): NCT00316836
Participation: Limited to MA.27 participants
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: April 24, 2006 Closing Date: July 31, 2008

Chair: (USA) Ms. Celine M. Vachon, NCCTG, Mayo Clinic, (507) 284-1159, (USA) Dr. Philip J. Stella, NCCTG, Mayo Clinic, (507) 284-1159, (USA) Dr. Wilma Lingle, NCCTG, Mayo Clinic, (507) 266-0954, (USA) Dr. James N. Ingle, NCCTG, Mayo Clinic, (507) 284-1887


Permanently Closed
MA29 (MA29)A Feasibility Study of Pre-Operative Sunitinib (SU11248) With Multiple Pharmacodynamic Endpoints in Patients with T1c-T3 Operable Carcinoma of the Breast.
A Feasibility Study of Pre-Operative Sunitinib (SU11248) With Multiple Pharmacodynamic Endpoints in Patients with T1c-T3 Operable Carcinoma of the Breast.

Eligibility: Women with newly diagnosed, histopathologically confirmed, T1c, T2 or T3 unifocal, operable, carcinoma of the breast (prior to surgery).

Objectives: PRIMARY: To assess the feasibility of administering oral sunitinib pre-operatively, to patients with newly diagnosed, histopathologically confirmed T1c, T2 or T3 unifocal, operable carcinoma of the breast. SECONDARY: - toxicity - tumour response (RECIST) - pharmacodynamic endpoints [treatment-induced changes (1) in the levels of tumour and plasma-soluble markers of angiogenesis, (2) in the protein/RNA levels of host and tumour-specific genes involved in response and toxicity to sunitinib, (3) on vascular parameters (DCE-MRI), (4) on cell death and tumour microcirculation (spectroscopic and microbubble contrast-enhanced ultrasound) and (5) on tumour metabolic activity (18-FDG-PET)] - tumour banking (optional)

NCT Registration ID (from clinicaltrials.gov): NCT00482755
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 12, 2007 Closing Date: March 15, 2010

Chair: (Canada) Dr. Maureen E. Trudeau, Odette Cancer Centre, (416) 480-5145


Permanently Closed
MA4National Cancer Institute Of Canada Cooperative Clinical Trial Of Adjuvant Post-Surgical Treatment Of Breast Carcinoma In Post-Menopausal Patients With Histologically Involved Axillary Nodes
National Cancer Institute Of Canada Cooperative Clinical Trial Of Adjuvant Post-Surgical Treatment Of Breast Carcinoma In Post-Menopausal Patients With Histologically Involved Axillary Nodes

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 13, 1984 Closing Date: December 31, 1990

Chair: (Canada) Dr. Alexander H.G. Paterson, Tom Baker Cancer Centre, (403) 521-3688, (Canada) Dr. Sheldon Fine, Credit Valley Hospital, (905) 813-1100 Ext. 5135


Permanently Closed
MA5Cooperative Clinical Trial of Intensive CEF versus Standard CMF as Adjuvant Therapy for Breast Carcinoma in Premenopausal Patients With Histologically Involved Axillary Nodes
Cooperative Clinical Trial of Intensive CEF versus Standard CMF as Adjuvant Therapy for Breast Carcinoma in Premenopausal Patients With Histologically Involved Axillary Nodes

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 01, 1989 Closing Date: July 30, 1993

Chair: (Canada) Dr. Mark Levine, Henderson Hospital, (905) 527-4322 Ext. 42176


Permanently Closed
MA6APhase I Study of Fluorouracil, Doxorubicin and Vinorelbine (FAN) in Patients With Advanced Breast Cancer
Phase I Study of Fluorouracil, Doxorubicin and Vinorelbine (FAN) in Patients With Advanced Breast Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 06, 1992 Closing Date: July 07, 1994

Permanently Closed
MA7APhase I Study of Fluorouracil With Folinic Acid, Doxorubicin and Vinorelbine (SuperFAN) in Patients With Advanced Breast Cancer
Phase I Study of Fluorouracil With Folinic Acid, Doxorubicin and Vinorelbine (SuperFAN) in Patients With Advanced Breast Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 10, 1992 Closing Date: May 24, 1994

Permanently Closed
MA8A Phase III Comparative Study of Vinorelbine Combined With Doxorubicin versus Doxorubicin Alone in Disseminated Metastatic/Recurrent Breast Cancer
A Phase III Comparative Study of Vinorelbine Combined With Doxorubicin versus Doxorubicin Alone in Disseminated Metastatic/Recurrent Breast Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 15, 1992 Closing Date: July 17, 1995

Permanently Closed
MA9 (8814)Phase III Comparison of Adjuvant Chemoendocrine Therapy with CAF and Concurrent or Delayed Tamoxifen to Tamoxifen Alone in Postmenopausal Patients with Involved Axillary Lymph Nodes and Positive Receptors
Phase III Comparison of Adjuvant Chemoendocrine Therapy with CAF and Concurrent or Delayed Tamoxifen to Tamoxifen Alone in Postmenopausal Patients with Involved Axillary Lymph Nodes and Positive Receptors

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: November 21, 1991 Closing Date: July 31, 1995

Chair: (USA) Dr. Kathy S. Albain, Loyola University Medical Center, (708) 327-3102, (Canada) Dr. Michael Brundage, Cancer Centre of Southeastern Ontario at Kingston, (613) 549-6666 Ext. 4506


Permanently Closed
MA9C (8854)Prognostic Factor Panel to Predict Preferred Therapy for Node-Positive Postmenopausal Breast Cancer Patients
Prognostic Factor Panel to Predict Preferred Therapy for Node-Positive Postmenopausal Breast Cancer Patients

NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: May 01, 1996 Closing Date: October 01, 1998

Permanently Closed
MAC2 (B-33)A Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of Exemestane in Clinical Stage T1-3 N0-1 M0 Postmenopausal Breast Cancer Patients Completing at Least Five Years of Tamoxifen Therapy (NSABP: B-33).
A Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of Exemestane in Clinical Stage T1-3 N0-1 M0 Postmenopausal Breast Cancer Patients Completing at Least Five Years of Tamoxifen Therapy (NSABP: B-33).

NCT Registration ID (from clinicaltrials.gov): NCT00016432
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: June 03, 2002 Closing Date: October 09, 2003

Chair: (Canada) Dr. Andrea Eisen, Odette Cancer Centre, (416) 480-4617


Permanently Closed
MAC3 (E2100)A Randomized Phase III Trial of Paclitaxel Versus Paclitaxel Plus Bevacizumab (rhuMAb VEGF) as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer.
A Randomized Phase III Trial of Paclitaxel Versus Paclitaxel Plus Bevacizumab (rhuMAb VEGF) as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer.

Eligibility: Patients must have histologically or cytologically confirmed adenocarcinoma of the breast with measurable or nonmeasurable locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent. All scans or x-rays used to document measurable or nonmeasurable disease must be done within 4 weeks prior to randomization. Patients with breast cancer overexpressing HER-2 (gene amplification by FISH or 3+ overexpression by immunohistochemistry) are not eligible unless they have received prior therapy with Herceptin. HER-2 testing is strongly encouraged. Therefore patients with unknown HER-2 status are not eligible unless the treating physician has determined that Herceptin-based therapy would be inappropriate or not indicated. Patients must not have had prior chemotherapy for locally recurrent or metastatic breast cancer. Prior hormonal therapy for locally recurrent or metastatic disease is allowed, but this must have been discontinued

Objectives: To determine the time to treatment failure of patients with chemotherapy naive metastatic breast cancer randomized to treatment with either paclitaxel alone or paclitaxel plus bevacizumab. To compare the objective response rate, duration of response, overall survival and time to progression of paclitaxel to that of the combination of paclitaxel plus bevacizumab. To compare the toxicity of paclitaxel to that of paclitaxel in combination with bevacizumab. To compare the quality of life (FACT-B) of patients treated with paclitaxel to that of the combination of paclitaxel plus bevacizumab as first-line therapy for metastatic breast cancer. To compare changes in surrogate markers of angiogenesis and response including VEGF and VCAM-1 expression during treatment with paclitaxel to that of paclitaxel plus bevacizumab.

NCT Registration ID (from clinicaltrials.gov): NCT00028990
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: June 26, 2002 Closing Date: May 26, 2004

Permanently Closed
MAC6 (26-02)A Phase III Trial Evaluating the Role of Chemotherapy as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer who Receive Endocrine Therapy
A Phase III Trial Evaluating the Role of Chemotherapy as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer who Receive Endocrine Therapy

Complexity Level: 2

Eligibility: Premenopausal women with histologically proven, resected breast cancer with ER and/or PgR positive tumors for whom there is an uncertain role for adding chemotherapy to the adjuvant treatment program. Patients should be randomized within 12 weeks after surgery prior to commencing any adjuvant systemic therapy.

Objectives: This trial will evaluate the worth of adding adjuvant chemotherapy for premenopausal women with steroid hormone receptor positive early invasive breast cancer who receive ovarian function suppression plus either tamoxifen or exemestane for five years. The use of chemotherapy will be determined by randomization. The method of ovarian function suppression (GnRH analogue for five years, surgical oophorectomy or ovarian irradiation) and the choice of tamoxifen or exemestane will be determined by the investigator.

Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: August 04, 2003 Closing Date: November 22, 2005

Permanently Closed
MAP1A Randomized Feasibility Study of Letrozole in Postmenopausal Women at Increased Risk for Development of Breast Cancer as Evidenced by High Breast Density
A Randomized Feasibility Study of Letrozole in Postmenopausal Women at Increased Risk for Development of Breast Cancer as Evidenced by High Breast Density

Eligibility: Healthy, postmenopausal women or those postmenopausal women who have had prior breast cancer with a receptor positive tumour, either ER or PR or equivocal or unknown breast cancer or who have had prior DCIS (receptor status not required), who have either not had adjuvant endocrine therapy or are more than six months from the completion of adjuvant endocrine therapy and who are eligible by virtue of the appearance of increased radiological density, grade 4, 5 or 6, on routine mammographic screening

Objectives: To determine the proportion of women who have a decrease in breast density of at least one grade after treatment for one year; to determine if the decrease in density grade is sustained one year after cessation of therapy; to evaluate specific changes related to other end-organ effects i.e. bone density, lipid metabolism, etc.

NCT Registration ID (from clinicaltrials.gov): NCT00238316
Participation: Not limited
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 05, 2000 Closing Date: June 09, 2006

Chair: (Canada) Dr. David Warr, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 2260, (USA) Dr. Paul Goss, Massachusetts General Hospital Cancer Center, (617) 724-3118


Permanently Closed
MAP2A Randomized Study of the Effect of Exemestane (Aromasin) versus Placebo on Breast Density in Postmenopausal Women at Increased Risk for Development of Breast Cancer
A Randomized Study of the Effect of Exemestane (Aromasin) versus Placebo on Breast Density in Postmenopausal Women at Increased Risk for Development of Breast Cancer

Eligibility: Healthy, postmenopausal women who have increased radiological density occupying >25% of the breast tissue on routine screening mammogram.

Objectives: To determine whether treatment with exemestane for one year in women with spontaneously increased breast density leads to a decrease in breast density of at least >1 grade 12 months after randomization; to determine if the decrease in breast density grade is sustained one year after stopping treatment; to determine the correlation between the grade of breast density and bone density at base line and at 12 months; to assess overall safety (bone and lipid metabolism, toxicity); to compare menopause-specific quality of life.

NCT Registration ID (from clinicaltrials.gov): NCT00066586
Participation: Not limited
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 01, 2001 Closing Date: June 09, 2006

Chair: (USA) Dr. Paul Goss, Massachusetts General Hospital Cancer Center, (617) 724-3118


Permanently Closed
MAP3BThe Influence of Five Years of Exemestane on Bone Mineral Density in Postmenopausal Women at Increased Risk of Developing Breast Cancer - A Companion Study to MAP.3
The Influence of Five Years of Exemestane on Bone Mineral Density in Postmenopausal Women at Increased Risk of Developing Breast Cancer - A Companion Study to MAP.3

Complexity Level: 3

Eligibility: Woman randomized to MAP.3 with: a BMD of Spine (L1-L4)or Total Hip and Femoral Neck, T score >= -1.9 sd are eligible for this study.

Objectives: To examine whether there is clinically relevant difference in impact on BMD between exemestane and placebo after two years from randomization to the core protocol.

NCT Registration ID (from clinicaltrials.gov): NCT00688246
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 23, 2008 Closing Date: March 23, 2010

Chair: (USA) Dr. Paul Goss, Massachusetts General Hospital Cancer Center, (617) 724-3118


Permanently Closed