Phase 3 Study to evaluate Talazoparib (BMN 673) versus Physician's Choice in BRCA Metastatic Breast Cancer, with prior Chemotherapy Regimens for Metastatic Disease

Phase 1

• Conditions: Germline BRCA Mutation Subjects with Locally Advanced and/or Metastatic Breast Cancer; MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-002716-28-DE
• Lead Sponsor: Medivation, Inc., a wholly-owned subsidiary of Pfizer, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-11
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 431

Inclusion Criteria

•Histologically or cytologically confirmed carcinoma of the breast
•Locally advanced breast cancer that is not amendable to curative radiation or surgical cure and/or metastatic desease appropriate for systemic single cytotoxic chemotherapy
• Deleterious, suspected deleterious or pathogenic germline BRCA1 or BRCA2 mutation
• No more than 3 prior chemotherapy - inclusive regimes for locally advanced and/or metastatic disease
• Prior treatment with a taxane and/or anthracycline in the neoadjuvant, adjuvant,locally adjuvanced, or metstatic setting
• ECOG performance status = 2
•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 375
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54

Exclusion Criteria

•Prior treatment with a PARP inhibitor (not included iniparib)
• Subjects who add objective disease progression while receiving platinium chemotherapy administereed for locally advanced or metastatic disease.
• Subjects who received platinium in the adjuvant or neoadjuvant setting are eligible
• CNS metastases except adequately treated brain metastases documented by baseline CT or MRI scan that has not progresses since previous scans and that does not require corticosteroids (except prednisone less than or equal to 5mg/day) for management of CNS symptoms
• Prior malignancy except for prior BRCA-associated cancer as long as ther is no current evidence of the prior cancer, carcinmona in situ or non-melanoma skin cancer, and a cancer diagnosed and denitively treated =5 years before randomization with no subsequent evidence of recurrence
•Known to be human HIV positive, active hepatitis C virus, or active hepatitis B virus
•Known hypersensitivity of any of the components of talazoparib

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 compare PFS of subjects treated with talazoparib as a monotherapy relative to those treated with protocol-specific physician’s choice.;Secondary Objective: The secondary objectives of the study are to evaluate the following:<br>- Objective response rate (ORR)<br>- Overall survival (OS)<br>- Safety<br>- Pharmacokinetics of talazoparib;Primary end point(s): Progression-Free Survival (PFS);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): Overall Response Rate (ORR), Overall-Survival (OS);Timepoint(s) of evaluation of this end point: Anticipated in about 24-30 months following first patient enrolled