Phase II Study of AZD2281 in Patients With Known BRCA Mutation Status or Recurrent High Grade Ovarian Cancer or Patients With Known BRCA Mutation Status/ Triple Neg Breast Cancer

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Ovarian Carcinoma

Treatments: Drug: AZD2281

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00679783

D0810C00020

Details and patient eligibility

About

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

Enrollment: 99 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed high grade serous and/or undifferentiated carcinoma of ovary, fallopian tube or peritoneum
• Oestrogen, progesterone and HER2 negative advanced adenocarcinoma of the breast
• Known BRCA positive breast cancer or ovarian cancer, that is not high grade serous or undifferentiated tubo-ovarian carcinoma.
• Performance status of no more than 2.

Exclusion criteria

• Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry
• Major surgery with 4 weeks of entering the study and must have recovered from effects of any major surgery .

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 4 patient groups

1

Experimental group

Description:

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

Treatment:

Drug: AZD2281

2

Experimental group

Description:

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

Treatment:

Drug: AZD2281

3

Experimental group

Description:

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

Treatment:

Drug: AZD2281

4

Experimental group

Description:

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

Treatment:

Drug: AZD2281