Phase 2 Study to evaluate talazoparib (BMN 673) in Patients with Germline BRCA Mutations with Locally Advanced and/or Metastatic Breast Cancer
- Conditions
- ocally advanced and/or metastatic breast cancer with germline BRCA1 or BRCA2 mutationsMedDRA version: 20.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-003076-12-GB
- Lead Sponsor
- Medivation, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 84
Inclusion Criteria:
Histologically or cytologically confirmed carcinoma of the breast
Locally advanced and/or metastatic disease
Deleterious or pathogenic germline BRCA 1 or BRCA 2 mutation
Prior chemotherapy: Cohort 1) PR or CR to prior platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum; or Cohort 2) > 2 prior chemotherapy regimens for metastatic disease and no prior platinum for metastatic disease
ECOG performance status = 1
Have adequate organ function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 84
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14
Prior enrollment into a clinical trial of a PARP inhibitor
CNS metastasis except adequately treated brain metastasis documented by baseline CT or MRI scan that has not progressed since previous scans and that does not require corticosteroids for management of CNS symptoms
Prior malignancy except for prior BRCA-associated cancer as long as there is no current evidence of the prior cancer, carcinoma in situ of the cervix or non-melanoma skin cancer, and a cancer diagnosed and definitively treated >5 years prior to study enrollment with no subsequent evidence of recurrence
Known to be HIV positive, active hepatitis C virus, or active hepatitis B virus
Known hypersensitivity to any of the components of BMN 673
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to determine the objective response rate (ORR) for each cohort treated with BMN 673 as a single agent. The ORR will be based on confirmed responses as defined by Response Evaluation Criteria in Solid Tumors (RECIST). ;<br> Secondary Objective: The secondary objectives of the study are to evaluate the following:<br> - Clinical benefit response (CBR) rate as defined as CR + partial response (PR) + SD lasting = 24 weeks<br> - Duration of response (DOR) for CR and PR<br> - PFS<br> -Overall survival (OS)<br> -Safety<br> -Pharmacokinetics of BMN 673<br> ;Primary end point(s): Overall response rate (ORR);Timepoint(s) of evaluation of this end point: Anticipated in about 24-30 months following first patient enrolled
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Clinical Benefit Response (CBR) (CR + PR + SD lasting = 24 weeks), Duration of Response (DOR) for responding subjects (CR + PR, subset analysis) by IRF evaluation, Progression Free Survival (PFS), and Overall Survival (OS);Timepoint(s) of evaluation of this end point: Primary efficacy analysis will be performed after the last subject has had the opportunity to be confirmed as a responder if the subject responds within 18 weeks