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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

A Phase 3, Open-label, Randomized Parallel,2-arm,Multi-center Study Of Talazoparib(Bmn 673) Versus Physician's Choice In Germline Brca Mutation Subjects With Locally Advanced And/or Metastatic Breast Cancer, Who Have Received Prior Chemotherapy Regimens For Metastatic Disease

Keywords

Breast Neoplasms BRCA 1 Gene Mutation BRCA 2 Gene Mutation Breast cancer BRCA mutation PARP inhibitor BRCA 1 BRCA 2 Poly(ADP-ribose) Polymerase Inhibitors Talazoparib

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California, San Francisco: Helen Diller Comprehensive Cancer Center
    San Francisco, California, 94115, United States
  • Kaiser Permanente Medical Center
    San Francisco, California, 94115, United States
  • California Oncology of the Central Valley
    Fresno, California, 93710, United States
  • Kaiser Permanente Medical Center
    South San Francisco, California, 94080, United States
  • Marin Cancer Care, Inc.
    Greenbrae, California, 94904, United States
  • Kaiser Permanente Medical Center
    Oakland, California, 94611, United States
  • Kaiser Permanente Medical Center
    San Leandro, California, 94577, United States
  • Kaiser Permanente Medical Center Lab Drawing Station
    Martinez, California, 94553, United States
  • Kaiser Permanente Medical Center Lab Drawing Station
    Redwood City, California, 94063, United States
  • Kaiser Permanente Medical Center
    Walnut Creek, California, 94596, United States
  • Freidenrich Center for Translational Research (CTRU)
    Stanford, California, 94305, United States
  • Investigational Pharmacy/Drug Shipment, Martha Hamilton, Investigational Drug Services
    Stanford, California, 94305, United States
  • Stanford Cancer Institute
    Stanford, California, 94305, United States
  • Stanford University Hospital and Clinics
    Stanford, California, 94305, United States
  • Stanford Women's Cancer Center
    Stanford, California, 94305, United States
  • Kaiser Permanente Medical Center
    Vallejo, California, 94589, United States
  • Kaiser Permanente Medical Center Lab Drawing Station
    Mountain View, California, 94041, United States
  • Kaiser Permanente Medical Center Lab Drawing Station
    Antioch, California, 94509, United States
  • Kaiser Permanente Medical Center Lab Drawing Station
    Milpitas, California, 95035-5491, United States
  • Kaiser Permanente Medical Center
    Santa Clara, California, 95051, United States
  • Kaiser Permanente Medical Center Lab Drawing Station
    Antioch, California, 94531, United States
  • Kaiser Permanente Medical Center Lab Drawing Station
    Fairfield, California, 94533-6901, United States
  • Kaiser Permanente Medical Center Lab Drawing Station
    Napa, California, 94558-3313, United States
  • Kaiser Permanente Medical Center Lab Drawing Station
    Pleasanton, California, 94558, United States
  • Kaiser Permanente Medical Center
    San Jose, California, 95119, United States
  • Sutter Santa Rose Regional Hospital
    San Francisco, California, 95403, United States
  • Sutter North Bay Health Plaza
    Santa Rosa, California, 95403, United States
  • Sutter Pacific Medical Foundation
    Santa Rosa, California, 95403, United States
  • Kaiser Permanente Medical Center Lab Drawing Station
    Gilroy, California, 95020, United States
  • Kaiser Permanente Medical Center Lab Drawing Station
    Modesto, California, 95356, United States
  • Kaiser Permanente Medical Center
    Sacramento, California, 95825, United States
  • Kaiser Permanente Medical Center
    Roseville, California, 95661, United States
  • CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
    Bakersfield, California, 93309, United States
  • San Luis Obispo Oncology and Hematology Health Center/Pacific Central Coast Health Centers
    San Luis Obispo, California, 93401, United States
  • Central Coast Medical Oncology Corporation
    Santa Maria, California, 93454, United States
  • Cancer center of Santa Barbara With Sansum Clinic
    Solvang, California, 93463, United States
  • Cancer center of Santa Barbara With Sansum Clinic
    Santa Barbara, California, 93105, United States
  • Sansum Clinic
    Santa Barbara, California, 93105, United States
  • Santa Barbara Cottage Hospital
    Santa Barbara, California, 93105, United States
  • Southern California Permanente Medical Group
    Woodland Hills, California, 91367, United States
  • Los Angeles Hematology Oncology Medical Group
    Glendale, California, 91206, United States
  • Los Angeles Hematology Oncology Medical Group
    Glendale, California, 91204, United States
  • The Oncology Institute of Hope and Innovation
    Glendale, California, 91204, United States
  • UCLA Hematology-Oncology
    Santa Monica, California, 90404, United States
  • UCLA Santa Monica Medical Center & Orthopaedic Hospital
    Santa Monica, California, 90404, United States
  • Los Angeles Hematology Oncology Medical Group
    Los Angeles, California, 90057, United States
  • Los Angeles Hematology Oncolgy Medical Group
    Los Angeles, California, 90017, United States
  • The Oncology Institute of Hope and Innovation
    Los Angeles, California, 90033, United States
  • The Oncology Institute of Hope and Innovation
    Montebello, California, 90640, United States
  • The Oncology Institute of Hope and Innovation
    West Covina, California, 91790, United States
  • The Oncology Institute of Hope and Innovation
    Downey, California, 90241, United States
  • The Oncology Institute of Hope and Innovation
    Lynwood, California, 90262, United States
  • The Oncology Institute of Hope and Innovation
    Whittier, California, 90602, United States
  • Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer care Associates
    Redondo Beach, California, 90277, United States
  • The Oncology Institute of Hope and Innovation
    Torrance, California, 90503, United States
  • The Oncology Institute of Hope and Innovation
    Long Beach, California, 90805, United States
  • ICRI
    Whittier, California, 90603, United States
  • UCLA West Medical Pharmacy Attn: Steven L. Wong, PharmD
    Los Angeles, California, 90095-1772, United States
  • UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm. D.
    Los Angeles, California, 90095-7349, United States
  • UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.
    Los Angeles, California, 90095-7349, United States
  • UCLA West Medical Pharmacy, Attn:Steven L. Wong, Pharm.D.
    Los Angeles, California, 90095-7349, United States
  • UCLA West Medical Pharmacy, Attn:Steven L. Wong,Pharm.D.
    Los Angeles, California, 90095-7349, United States
  • UCLA West Medical Pharmacy
    Los Angeles, California, 90095-7349, United States
  • Ronald Reagan UCLA Medical Center, Drug Information Center
    Los Angeles, California, 90095, United States
  • Ronald Reagan UCLA Medical Center
    Los Angeles, California, 90095, United States
  • TRIO-US Central Administration
    Los Angeles, California, 90095, United States
  • UCLA Hematology-Oncology
    Los Angeles, California, 90095, United States
  • UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.
    Los Angeles, California, 90095, United States
  • St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
    Fullerton, California, 92835, United States
  • The Oncology Institute of Hope and Innovation
    Anaheim, California, 92801, United States
  • The Oncology Institute of Hope and Innovation
    Santa Ana, California, 92705, United States
  • Comprehensive Cancer Centers of Nevada
    Las Vegas, Nevada, 89128, United States
  • Comprehensive Cancer Centers of Nevada
    Las Vegas, Nevada, 89148, United States
  • Comprehensive Cancer Centers of Nevada
    Las Vegas, Nevada, 89169, United States
  • Comprehensive Cancer Centers of Nevada
    Henderson, Nevada, 89052, United States
  • Comprehensive Cancer Centers of Nevada
    Henderson, Nevada, 89074, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT01945775
Phase
Phase 3
Lead Scientist
Hope Rugo
Study Type
Interventional
Last Updated
September 8, 2017