Canadian Cancer Trials Group Bulletins

Trial Management Group


Trial Activations

The following trials were recently centrally activated:

Canadian Cancer Trials Group MA.38 - 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

The purpose of this study is to compare the progression-free survival of two different dose regimens of palbociclib in combination with endocrine therapy (fulvestrant or tamoxifen or AI) as second line therapy in women with ER positive, HER2 negative, advanced/metastatic breast cancer.

Secondary objectives are to evaluate and compare between the two treatment arms with respect to:
  • Safety and Tolerability
  • Response Rate (in patients with measurable disease)
  • Duration of Response
  • Clinical Benefit Rate
  • Overall Survival
The planned sample size is 180 patients.

For more information, interested centres should contact Chad Winch, Study Coordinator, at cwinch@ctg.queensu.ca or 613-533-6430.
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Canadian Cancer Trials Group MAC.19 (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

The primary objective of this study is 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.

Secondary objectives include:
  • 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 the incidence of invasive loco-regional recurrences in patients with a positive SLN(s) after completion of neoadjuvant chemotherapy.
  • For each treatment arm:
    • To obtain an estimate of the distribution of residual disease burden scores.
    • To estimate the distribution of overall survival.
Planned sample size is 2918 patients.

For more information, interested centres should contact Cathy Davidson, Study Coordinator, at cdavidson@ctg.queensu.ca or 613-533-6430.