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A Study Evaluating Talazopari...

A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)

NCT ID: NCT01945775

Last Updated: 2022-01-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

431 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-14

Study Completion Date

2021-03-05

Brief Summary

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The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician's choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations.

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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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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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talazoparib

Patient will be randomized 2:1 to receive talazoparib oral capsules (1.0 mg) once daily for 21 continuous days

Group Type EXPERIMENTAL

talazoparib

Intervention Type DRUG

Until progression or unacceptable toxicity develops

Physician's-Choice

Capecitabine, Eribulin, Gemcitabine or Vinorelbine

Group Type ACTIVE_COMPARATOR

Physician's-Choice

Intervention Type DRUG

Capecitabine, Eribulin, Gemcitabine or Vinorelbine

Interventions

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talazoparib

Until progression or unacceptable toxicity develops

Intervention Type DRUG

Physician's-Choice

Capecitabine, Eribulin, Gemcitabine or Vinorelbine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed carcinoma of the breast
* Locally advanced breast cancer that is not amenable to curative radiation or surgical cure and/or metastatic disease appropriate for systemic single cytotoxic chemotherapy
* Documentation of a deleterious, suspected deleterious, or pathogenic germline BRCA1 or BRCA2 mutation from Myriad Genetics or other laboratory approved by the Sponsor
* No more than 3 prior chemotherapy-inclusive regimens for locally advanced and/or metastatic disease (no limit on prior hormonal therapies or targeted anticancer therapies such as mechanistic target of rapamycin (mTOR) or CDK4/6 inhibitors, immune-oncology agents, tyrosine kinase inhibitors, or monoclonal antibodies against CTL4 or VEGF)
* Prior treatment with a taxane and/or anthracycline in the neoadjuvant, adjuvant, locally advanced, or metastatic setting unless medically contraindicated
* Have measurable or non-measurable, evaluable disease by the revised response evaluation criteria in solid tumors (RECIST) v.1.1
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria

* First-line locally advanced and/or metastatic breast cancer with no prior adjuvant chemotherapy unless the Investigator determines that one of the 4 cytotoxic chemotherapy agents in the control arm would otherwise be offered to the subject
* Prior treatment with a PARP inhibitor (not including iniparib)
* Not a candidate for treatment with at least 1 of the treatments of protocol-specific physician's choice (ie, capecitabine, eribulin, gemcitabine, vinorelbine)
* Subjects who had objective disease progression while receiving platinum chemotherapy administered for locally advanced or metastatic disease; subjects who received low-dose platinum therapy administered in combination with radiation therapy are not excluded
* Subjects who have received platinum in the adjuvant or neoadjuvant setting are eligible; however, subjects may not have relapsed within 6 months of the last dose of prior platinum therapy
* Cytotoxic chemotherapy within 14 days before randomization
* Radiation or anti-hormonal therapy or other targeted anticancer therapy within 14 days before randomization
* HER2 positive breast cancer
* Active inflammatory breast cancer
* CNS metastases

* Exception: Adequately treated brain metastases documented by baseline CT or MRI scan that has not progressed since previous scans and that does not require corticosteroids (except prednisone ≤ 5 mg/day or equivalent) for management of CNS symptoms. A repeat CT or MRI following the identification of CNS metastases (obtained at least 2 weeks after definitive therapy) must document adequately treated brain metastases.
* Subjects with leptomeningeal carcinomatosis are not permitted
* Prior malignancy except for any of the following:

* Prior BRCA-associated cancer as long as there is no current evidence of the cancer
* Carcinoma in situ or non-melanoma skin cancer
* A cancer diagnosed and definitively treated ≥ 5 years before randomization with no subsequent evidence of recurrence
* Known to be human immunodeficiency virus positive
* Known active hepatitis C virus, or known 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 Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Arizona Oncology Associates P.C. - NAHOA

Flagstaff, Arizona, United States

Site Status

HonorHealth

Scottsdale, Arizona, United States

Site Status

Virginia G. Piper Cancer Pharmacy

Scottsdale, Arizona, United States

Site Status

Kaiser Permanente Medical Center Lab Drawing Station

Antioch, California, United States

Site Status

Kaiser Permanente Medical Center Lab Drawing Station

Antioch, California, United States

Site Status

CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

Bakersfield, California, United States

Site Status

Kaiser Permanente Medical Center Lab Drawing Station

Fairfield, California, United States

Site Status

St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare

Fullerton, California, United States

Site Status

Kaiser Permanente Medical Center Lab Drawing Station

Gilroy, California, United States

Site Status

Los Angeles Hematology Oncology Medical Group

Glendale, California, United States

Site Status

Los Angeles Hematology Oncology Medical Group

Glendale, California, United States

Site Status