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A Phase 2, 2-Stage, 2-Cohort ...

A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study)

NCT ID: NCT02034916

Last Updated: 2019-10-14

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-13

Study Completion Date

2018-10-31

Brief Summary

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The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to either Cohort 1 or 2 based on prior chemotherapy for metastatic disease:

* Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for metastatic disease with disease progression \> 8 weeks following the last dose of platinum; or
* Cohort 2) Subjects who have received \> 2 prior chemotherapy regimens for metastatic disease and who have had no prior platinum therapy for metastatic disease

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Detailed Description

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Conditions

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Breast Neoplasms BRCA 1 Gene Mutation BRCA 2 Gene Mutation

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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talazoparib

Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for metastatic disease with disease progression \> 8 weeks following the last dose of platinum

Cohort 2) Subjects who have received \> 2 prior chemotherapy regimens for metastatic disease and who have had no prior platinum therapy for metastatic disease

Group Type EXPERIMENTAL

talazoparib

Intervention Type DRUG

Interventions

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talazoparib

Intervention Type DRUG

Other Intervention Names

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MDV3800 BMN673

Eligibility Criteria

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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

Exclusion Criteria

* 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 talazoparib

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Marin Cancer Care, Inc.

Greenbrae, California, United States

Site Status

UCLA West Medical Pharmacy Attn: Steven L. Wong, PharmD

Los Angeles, California, United States

Site Status

UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.

Los Angeles, California, United States

Site Status

TRIO-US Central Administration

Los Angeles, California, United States

Site Status

Stanford Women's Cancer Center

Palo Alto, California, United States

Site Status

UCLA Hematology Oncology- Porter Ranch

Porter Ranch, California, United States

Site Status

Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates

Redondo Beach, California, United States

Site Status

University of California, San Francisco: Helen Diller Comprehensive Cancer Center

San Francisco, California, United States

Site Status

UCLA Hematology-Oncology

Santa Monica, California, United States

Site Status

Stanford Cancer Institute

Stanford, California, United States

Site Status

Stanford Hospital and Clinics

Stanford, California, United States

Site Status

Sylvester at Deerfield Beach

Deerfield Beach, Florida, United States

Site Status

Memorial Cancer Institute at Memorial Regional Hospital

Hollywood, Florida, United States

Site Status

Memorial Regional Hospital

Hollywood, Florida, United States

Site Status

University of Miami Hospital & Clinics

Miami, Florida, United States

Site Status

Memorial Breast Cancer Center at Memorial Hospital West

Pembroke Pines, Florida, United States

Site Status

Memorial Cancer Institute at Memorial Hospital West

Pembroke Pines, Florida, United States

Site Status

Memorial Hospital West

Pembroke Pines, Florida, United States

Site Status