Canadian Cancer Trials Group Bulletins

Trial Management Group


Trial Activations

MA.37 (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)

The primary objective of this trial is 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).

Secondary objectives are 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); and,
  • Compare the safety of 2 years of palbociclib with adjuvant endocrine therapy versus adjuvant endocrine therapy alone.
Total sample size is 4600 patients. Centres interested in participating should contact Cathy Davidson, Study Coordinator, at wliu@ctg.queensu.ca.
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OVC.2 (NRG-GY0005): A Randomized Phase II/III study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women with Recurrent Platinum-resistant or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (COCOS)

The primary objective of this trial is to assess the efficacy and identify (in)active arm(s) of the combination of cediranib and olaparib, cediranib alone, olaparib alone, and physician's choice standard-of-care chemotherapy, as measured by progression-free survival in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer.

Secondary objectives are to:
  • Assess the efficacy of the combination of cediranib and olaparib, cediranib alone, olaparib alone, and physician's choice standard of care chemotherapy, as measured by objective response rate (ORR: partial or complete response) by RECIST criteria, in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer; and,
  • Assess safety endpoints, as measured by frequency and severity of adverse events by Common Terminology Criteria for Adverse Events (CTCAE) v.4.0.
Total sample size is 450 patients. Centres interested in participating should contact Wenling Liu, Study Coordinator, at wliu@ctg.queensu.ca.