Conditions: Ovarian Carcinoma Breast Cancer
Keywords: Breast cancer Ovarian cancer BRCA Triple negative Poly(ADP ribose) polymerases Known BRCA or Recurrent High Grade Serious/ Undifferentiated Tubo- Ovarian Carcinoma Known BRCA or Triple Negative Breast Cancer
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 99
Healthy volunteers: no

Brief summary:
This is a Phase II, open label, non randomized correlative study of AZD2281 in patients with recurrent breast and ovarian cancer in both BRCA inherited mutation carriers and non-carriers to identify objective response rate and to assess for early markers of activity and to assess correlative markers that may provide helpful information for subsequent clinical trials. Approximately 110 patients from 7 centers in Canada will be enrolled into this study

Detailed description:

Arms:
arm 1: Triple negative breast Cancer with unknown BRCA mutation status: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) administered orally

AZD2281, PARP inhibitor Olaparib tablets, oral arm 2: Known BRCA mutation positive breast cancer: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) to be administered orally

AZD2281, PARP inhibitor Olaparib tablets, oral arm 3: High grade serous/undifferentiated tubo-ovarian carcinoma with unknown BRCA status: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) administered orally

AZD2281, PARP inhibitor Olaparib tablets, oral arm 4: Known BRCA mutation positive ovarian cancer: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) administered orally

AZD2281, PARP inhibitor Olaparib tablets, oral

Interventions: intervention 1: AZD2281
Intervention descriptions: intervention 1: PARP inhibitor Olaparib tablets, oral

Protocol document: