ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01945775
Recruitment Status : Active, not recruiting
First Posted : September 19, 2013
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms BRCA 1 Gene Mutation BRCA 2 Gene Mutation Drug: talazoparib Drug: Physician's-Choice Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 431 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 14, 2013
Actual Primary Completion Date : September 15, 2017
Estimated Study Completion Date : December 27, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: talazoparib
Patient will be randomized 2:1 to receive talazoparib oral capsules (1.0 mg) once daily for 21 continuous days
Drug: talazoparib
Until progression or unacceptable toxicity develops
Active Comparator: Physician's-Choice
Capecitabine, Eribulin, Gemcitabine or Vinorelbine
Drug: Physician's-Choice
Capecitabine, Eribulin, Gemcitabine or Vinorelbine



Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Anticipated in about 41 months following first patient enrolled ]

Secondary Outcome Measures :
  1. Evaluate objective response rate (ORR) [ Time Frame: Anticipated in about 41 months following first patient enrolled ]
  2. Evaluate overall survival (OS) [ Time Frame: Anticipated in about 41 months following first patient enrolled ]
  3. Safety as assessed by percentage of patients with any Adverse Event (AE) [ Time Frame: Anticipated in about 41 months following first patient enrolled ]
  4. Pharmacokinetics of talazoparib as assessed by trough plasma concentrations [ Time Frame: Anticipated in about 41 months following first patient enrolled ]

Other Outcome Measures:
  1. Duration of response (DOR) for objective responders [ Time Frame: Anticipated in about 41 months following first patient enrolled ]
  2. Health-related quality of life [ Time Frame: Anticipated in about 41 months following first patient enrolled ]
    2 Validated questionnaires to assess general quality of life and deterioration due to breast cancer



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01945775


  Hide Study Locations
Locations
United States, Arizona
Arizona Oncology Associates, PC - NAHOA
Flagstaff, Arizona, United States, 86001
Arizona Oncology Associates, PC - NAHOA
Prescott Valley, Arizona, United States, 86314
Scottsdale Healthcare Hospitals DBA HonorHealth
Scottsdale, Arizona, United States, 85258
Virginia G. Piper Cancer Pharmacy (Drug shipment, preparation, storage only)
Scottsdale, Arizona, United States, 85258
Arizona Oncology Associates, PC - NAHOA
Sedona, Arizona, United States, 86336
United States, California
Kaiser Permanente Medical Center Lab Drawing Station
Antioch, California, United States, 94509
Kaiser Permanente Medical Center Lab Drawing Station
Antioch, California, United States, 94531
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
Kaiser Permanente Medical Center Lab Drawing Station
Fairfield, California, United States, 94533-6901
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
Fullerton, California, United States, 92835
Kaiser Permanente Medical Center Lab Drawing Station
Gilroy, California, United States, 95020
Los Angeles Hematology Oncology Medical Group
Glendale, California, United States, 91204
Los Angeles Hematology Oncology Medical Group
Glendale, California, United States, 91206
Marin Cancer Care, Inc.
Greenbrae, California, United States, 94904
Los Angeles Hematology Oncolgy Medical Group
Los Angeles, California, United States, 90017
Los Angeles Hematology Oncology Medical Group
Los Angeles, California, United States, 90057
UCLA West Medical Pharmacy Attn: Steven L. Wong, PharmD
Los Angeles, California, United States, 90095-1772
Drug Management Only: UCLA West Medical Pharmacy, Attn:Steven L. Wong, Pharm.D.
Los Angeles, California, United States, 90095-7349
UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm. D.
Los Angeles, California, United States, 90095-7349
UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.
Los Angeles, California, United States, 90095-7349
UCLA West Medical Pharmacy, Attn:Steven L. Wong, Pharm.D.
Los Angeles, California, United States, 90095-7349
UCLA West Medical Pharmacy, Attn:Steven L. Wong,Pharm.D.
Los Angeles, California, United States, 90095-7349
(IRB# 14-000105) Ronald Reagan UCLA Medical Center, Drug Information Center
Los Angeles, California, United States, 90095
Regulatory Managment Only: TRIO-US Central Administration
Los Angeles, California, United States, 90095
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
TRIO-US Central Administration
Los Angeles, California, United States, 90095
UCLA Hematology-Oncology
Los Angeles, California, United States, 90095
UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.
Los Angeles, California, United States, 90095
Kaiser Permanente Medical Center Lab Drawing Station
Martinez, California, United States, 94553
Kaiser Permanente Medical Center Lab Drawing Station
Milpitas, California, United States, 95035-5491
Kaiser Permanente Medical Center Lab Drawing Station
Modesto, California, United States, 95356
Kaiser Permanente Medical Center Lab Drawing Station
Mountain View, California, United States, 94041
Kaiser Permanente Medical Center Lab Drawing Station
Napa, California, United States, 94558-3313
Kaiser Permanente Medical Center
Oakland, California, United States, 94611
Freidenrich Center for Translational Research (CTRU)
Palo Alto, California, United States, 94304
Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer care Associates
Redondo Beach, California, United States, 90277
Kaiser Permanente Medical Center Lab Drawing Station
Redwood City, California, United States, 94063
Kaiser Permanente Medical Center
Roseville, California, United States, 95661
Kaiser Permanente Medical Center
Sacramento, California, United States, 95825
Southern California Permanente Medical Group
San Diego, California, United States, 92120
Kaiser Permanente Medical Center
San Francisco, California, United States, 94115
UCSF Helen Diller Comprehensive Cancer Center
San Francisco, California, United States, 94115
Kaiser Permanente Mission Bay Medical Center Lab Drawing Station
San Francisco, California, United States, 94518
Kaiser Permanente Medical Center
San Jose, California, United States, 95119
Kaiser Permanente Medical Center
San Leandro, California, United States, 94577
Pacific Central Coast Health Centers - San Luis Obispo Oncology and Hematology Health Center
San Luis Obispo, California, United States, 93401
Ridley Tree Cancer Center
Santa Barbara, California, United States, 93105
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93105
Kaiser Permanente Medical Center
Santa Clara, California, United States, 95051
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
UCLA Hematology-Oncology
Santa Monica, California, United States, 90404
UCLA Santa Monica Medical Center & Orthopaedic Hospital
Santa Monica, California, United States, 90404
Sutter North Bay Health Plaza
Santa Rosa, California, United States, 95403
Sutter Pacific Medical Foundation
Santa Rosa, California, United States, 95403
Sutter Santa Rosa Regional Hospital
Santa Rosa, California, United States, 95403
Ridley Tree Cancer Center
Solvang, California, United States, 93463
Kaiser Permanente Medical Center
South San Francisco, California, United States, 94080
Investigational Pharmacy/Drug Shipment, Investigational Drug Services
Stanford, California, United States, 94305
Stanford Cancer Institute
Stanford, California, United States, 94305
Stanford University Hospital and Clinics
Stanford, California, United States, 94305
Stanford Women's Cancer Center
Stanford, California, United States, 94305
Kaiser Permanente Medical Center
Vallejo, California, United States, 94589
Kaiser Permanente Medical Center
Walnut Creek, California, United States, 94596
Southern California Permanente Medical Group
Woodland Hills, California, United States, 91367
United States, Colorado
Rocky Mountain Cancer Centers
Aurora, Colorado, United States, 80012
ATTN-Research Pharmacist
Aurora, Colorado, United States, 80045
University of Colorado Cancer Center - Anschutz Cancer Pavilion(ACP)
Aurora, Colorado, United States, 80045
University of Colorado Hospital - Anschutz Inpatient Pavilion(AIP)
Aurora, Colorado, United States, 80045
University of Colorado Hospital - Anschutz Outpatient Pavilion(AOP)
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Centers
Boulder, Colorado, United States, 80303
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, United States, 80907
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80220
Rocky Mountain Cancer Centers
Lakewood, Colorado, United States, 80228
Rocky Mountain Cancer Centers
Littleton, Colorado, United States, 80120-4413
Rocky Mountain Cancer Centers
Lone Tree, Colorado, United States, 80124
UCHealth - Lone Tree Health Center
Lone Tree, Colorado, United States, 80124
UCHealth Lone Tree Health Center
Lone Tree, Colorado, United States, 80124
Rocky Mountain Cancer Centers
Longmont, Colorado, United States, 80501
Rocky Mountain Cancer Centers
Parker, Colorado, United States, 80138
Rocky Mountain Cancer Centers
Pueblo, Colorado, United States, 81008
Rocky Mountain Cancer Centers
Thornton, Colorado, United States, 80260
United States, Connecticut
Cancer Center of Central Connecticut
Plainville, Connecticut, United States, 06062
Cancer Center of Central Connecticut
Southington, Connecticut, United States, 06489
United States, Florida
Florida Cancer Specialists
Altamonte Springs, Florida, United States, 32701
Florida Cancer Specialists
Brandon, Florida, United States, 33511
Florida Cancer Specialists
Clearwater, Florida, United States, 33761
Sylvester at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Cancer Specialists of North Florida
Fleming Island, Florida, United States, 32003
Florida Cancer Specialists
Gainesville, Florida, United States, 32605
Memorial Breast Cancer Center at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Florida Cancer Specialists
Hudson, Florida, United States, 34667
Cancer Specialists of North Florida
Jacksonville Beach, Florida, United States, 32250
Cancer Specialists of North Florida
Jacksonville, Florida, United States, 32204
Cancer Specialists of North Florida
Jacksonville, Florida, United States, 32207
Cancer Specialists of North Florida, Pharmacy
Jacksonville, Florida, United States, 32256
Cancer specialists of North Florida
Jacksonville, Florida, United States, 32258
Florida Cancer Specialists
Lady Lake, Florida, United States, 32159
Florida Cancer Specialists
Largo, Florida, United States, 33770
Florida Cancer Specialists
Lecanto, Florida, United States, 34461
University of Miami Hospital and Clinics
Miami, Florida, United States, 33136
Sylvester at Kendall
Miami, Florida, United States, 33176
Florida Cancer Specialists
New Port Richey, Florida, United States, 34655
Florida Cancer Specialists
Orange City, Florida, United States, 32763
Florida Cancer Specialists
Orlando, Florida, United States, 32806
Orlando Health, Inc
Orlando, Florida, United States, 32806
Memorial Breast Cancer Center at Memorial Hospital West
Pembroke Pines, Florida, United States, 33028
Memorial Cancer Institute at Memorial Hospital West
Pembroke Pines, Florida, United States, 33028
Memorial Hospital West
Pembroke Pines, Florida, United States, 33028
Sylvester at Plantation
Plantation, Florida, United States, 33324
Cancer Specialists of North Florida
Saint Augustine, Florida, United States, 32086
Florida Cancer Specialists
Saint Petersburg, Florida, United States, 33705
Florida Cancer Specialists
Spring Hill, Florida, United States, 34608
Florida Cancer Specialists
Tampa, Florida, United States, 33607
Florida Cancer Specialists
Tavares, Florida, United States, 32778
United States, Georgia
Central Georgia Cancer Care, PC
Macon, Georgia, United States, 31201
Central Georgia Cancer Care, PC
Warner Robins, Georgia, United States, 31088-2259
United States, Indiana
Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
IU Health University Hospital
Indianapolis, Indiana, United States, 46202
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, United States, 46202
Investigational Drug Service, IUHSCC
Indianapolis, Indiana, United States, 46290
Springmill Medical Clinic
Indianapolis, Indiana, United States, 46290
United States, Kansas
The University of Kansas Cancer Center (Regulatory Office)
Fairway, Kansas, United States, 66205
The University of Kansas Cancer Center
Kansas City, Kansas, United States, 66112
The University of Kansas Cancer Center
Overland Park, Kansas, United States, 66210
The University of Kansas Cancer Center - Investigational Drug Services
Westwood, Kansas, United States, 66205
United States, Maryland
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States, 49506
United States, Minnesota
Minnesota Oncology Hematology, P.A.
Burnsville, Minnesota, United States, 55337
Minnesota Oncology Hematology, P.A.
Coon Rapids, Minnesota, United States, 55433
Minnesota Oncology Hematology, P.A.
Edina, Minnesota, United States, 55435-2150
Minnesota Oncology Hematology, P.A.
Fridley, Minnesota, United States, 55432
Minnesota Oncology Hematology, P.A.
Maplewood, Minnesota, United States, 55109
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States, 55404
Minnesota Oncology Hematology, P.A.
Saint Paul, Minnesota, United States, 55102-2389
Minnesota Oncology Hematology, P.A.
Woodbury, Minnesota, United States, 55125
United States, Mississippi
The West Clinic, P.C.
Corinth, Mississippi, United States, 38834
The West Clinic, P.C. d/b/a West Cancer Center
Southaven, Mississippi, United States, 38671
United States, Missouri
The University of Kansas Cancer Center
Kansas City, Missouri, United States, 64131
The University of Kansas Cancer Center
Kansas City, Missouri, United States, 64154
The University of Kansas Cancer Center
Lee's Summit, Missouri, United States, 64064
United States, Nevada
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89052
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89074
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89128
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89148
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
United States, New York
New York Oncology Hematology, P.C.
Albany, New York, United States, 12206
New York Oncology Hematology, P.C
Albany, New York, United States, 12208
Eastchester Center for Cancer Care
Bronx, New York, United States, 10469
New York Oncology Hematology, P.C.
Clifton Park, New York, United States, 12065
New York University Langone Medical Center
New York, New York, United States, 10016
Perlmutter Cancer Center
New York, New York, United States, 10016
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, United States, 10021
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States, 10065
Weill Cornell Breast Center
New York, New York, United States, 10065
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, United States, 10065
United States, North Carolina
Hope Women's Cancer Centers
Asheville, North Carolina, United States, 28806
Mission Hospital, Inc.
Asheville, North Carolina, United States, 28806
Novant Health Cancer Specialists
Charlotte, North Carolina, United States, 28204
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
Oncology Specialists of Charlotte
Charlotte, North Carolina, United States, 28207
Oncology Specialists of Charlotte
Charlotte, North Carolina, United States, 28226
Southern Oncology Specialists
Charlotte, North Carolina, United States, 28262
Lake Norman Hematology Oncology Specialists
Huntersville, North Carolina, United States, 28078
Novant Health Huntersville Medical Center
Huntersville, North Carolina, United States, 28078
Southern Oncology Specialists
Huntersville, North Carolina, United States, 28078
Novant Health Cancer Specialists
Matthews, North Carolina, United States, 28105
Novant Health Matthews Medical Center
Matthews, North Carolina, United States, 28105
Lake Norman Hematology Oncology Specialists
Mooresville, North Carolina, United States, 28117
United States, Oklahoma
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, United States, 74146
United States, Oregon
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States, 97213-2982
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States, 97225
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States, 97227
Northwest Cancer Specialists, P.C.
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
The Regional Cancer Center
Erie, Pennsylvania, United States, 16505
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
University of Pittsburgh Cancer Institute, Investigational Drug Service, William M. Cooper Pavilion
Pittsburgh, Pennsylvania, United States, 15232
University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
UPMC Cancer Center Uniontown
Uniontown, Pennsylvania, United States, 15401
United States, Tennessee
Tennessee Oncology, PLLC
Dickson, Tennessee, United States, 37055
Tennessee Oncology, PLLC
Franklin, Tennessee, United States, 37067
Tennessee Oncology, PLLC
Gallatin, Tennessee, United States, 37066
The West Clinic, P.C. d/b/a West Cancer Center
Germantown, Tennessee, United States, 38138
Tennessee Oncology, PLLC
Hermitage, Tennessee, United States, 37076
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Tennessee Oncology, PLLC
Lebanon, Tennessee, United States, 37090
The West Clinic, P.C. d/b/a West Cancer Center
Memphis, Tennessee, United States, 38104
Tennessee Oncology, PLLC
Murfreesboro, Tennessee, United States, 37129
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37067
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37129
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
The Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
The Sarah Cannon Research Instritute
Nashville, Tennessee, United States, 37203
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37211
Tennessee Oncology, PLLC
Shelbyville, Tennessee, United States, 37160
Tennessee Oncology, PLLC
Smyrna, Tennessee, United States, 37167
United States, Texas
The Center for Cancer and Blood Disorders
Arlington, Texas, United States, 76014
Texas Oncology-Austin Midtown
Austin, Texas, United States, 78705
Texas Oncology-Austin Central
Austin, Texas, United States, 78731
Texas Oncology-South Austin
Austin, Texas, United States, 78745
Texas Oncology-Austin North
Austin, Texas, United States, 78758
The Center for Cancer and Blood Disorders (Huguley)
Burleson, Texas, United States, 76028
Texas Oncology-Cedar Park
Cedar Park, Texas, United States, 78613
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Oncology-El Paso Cancer Treatment Center Grandview
El Paso, Texas, United States, 79902
Texas Oncology-El Paso Cancer Treatment Center Gateway
El Paso, Texas, United States, 79915
Texas Oncology - El Paso Cancer Treatment Center Joe Battle
El Paso, Texas, United States, 79938
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States, 76104
Investigational Products Center (IPC)
Fort Worth, Texas, United States, 76177
Texas Oncology-Memorial City
Houston, Texas, United States, 77024
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
U.T. MD Anderson Cancer Center
Houston, Texas, United States, 77030
US Oncology Investigational Products Center (IPC), (drug shipment only)
Irving, Texas, United States, 75063
US Oncology Investigational Products Center (IPC)
Irving, Texas, United States, 75063
US Oncology Investigational Products Center(IPC)
Irving, Texas, United States, 75063
Texas Oncology-Plano East
Plano, Texas, United States, 75075-7787
Texas Oncology-Seton Williamson
Round Rock, Texas, United States, 78665
Texas Oncology-Round Rock
Round Rock, Texas, United States, 78681
Texas Oncology - Waco
Waco, Texas, United States, 76712
Texas Oncology-Waco
Waco, Texas, United States, 76712
The Center for Cancer and Blood Disorders
Weatherford, Texas, United States, 76086
United States, Virginia
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Virginia Cancer Specialists, PC
Leesburg, Virginia, United States, 20176
Virginia Oncology Associates
Newport News, Virginia, United States, 23606
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Virginia Oncology Associates
Virginia Beach, Virginia, United States, 23456
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Swedish Medical Center First Hill, IDS Pharmacy
Seattle, Washington, United States, 98104
Swedish Medical Center
Seattle, Washington, United States, 98122
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States, 98683
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States, 98684
Australia, New South Wales
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
Australia, Queensland
Icon Cancer care Wesley
Auchenflower, Queensland, Australia, 4066
River City Pharmacy
Auchenflower, Queensland, Australia, 4066
Icon Cancer care Chermside
Chermside, Queensland, Australia, 4032
Icon Cancer care South Brisbane
South Brisbane, Queensland, Australia, 4101
Icon Cancer Care
South Brisbane, Queensland, Australia, 4101
Icon Cancer Foundation
South Brisbane, Queensland, Australia, 4101
Mater Adult Hospital
South Brisbane, Queensland, Australia, 4101
Icon Cancer care Southport
Southport, Queensland, Australia, 4215
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Adelaide Cancer Centre
Kurralta Park, South Australia, Australia, 5037
Ashford Cancer Centre Research
Kurralta Park, South Australia, Australia, 5037
Cancer Care SA PTY Ltd
Kurralta Park, South Australia, Australia, 5037
Cancer Care SA trading as Icon Pharmacy Adelaide
Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
Victoria Breast and Oncology Care
East Melbourne, Victoria, Australia, 3002
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia, 3199
Barwon Health
Geelong, Victoria, Australia, 3220
Austin Health, Heidelberg Repatriation Hospital
Heidelberg West, Victoria, Australia, 3079
Austin Health, The Austin Hospital
Melbourne, Victoria, Australia, 3084
Slade Pharmacy Mount Waverley
Mount Waverley, Victoria, Australia, 3149
Nova Pharmacy
Wendouree, Victoria, Australia, 3353
Ballarat Oncology & Haematology Services Clinical Trials Unit
Wendouree, Victoria, Australia, 3355
Ballarat Oncology & Haematology Services
Wendouree, Victoria, Australia, 3355
Australia, Western Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Belgium
Universitair Ziekenhuis Gent
Gent, Belgium, B-9000
CHU Sart Tilman Liege
Liege, Belgium, B-4000
Brazil
Instituto Nacional do Cancer Jose de Alencar Gomes da silva
Rio de Janeiro, RJ, Brazil, 20230-130
Central de Quimioterapia - HCIII
Rio de Janeiro, RJ, Brazil, 20560-120
Hospital do Cancer III - INCA / Instituto Nacional do Cancer / MS INCA HCIII
Rio de Janeiro, RJ, Brazil, 20560-120
Hopital da Cidade de Passo Fundo
Passo Fundo, RS, Brazil, 99010-260
Associacao Hospitalar Moinhos de Vento
Porto Alegre, RS, Brazil, 90035-001
Hospital de Clinicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-903
Uniao Brasileira de Educacao E Assistencia
Porto Alegre, RS, Brazil, 90610-000
Hospital do Cancer de Barretos - Fundacao Pio XII
Barretos, SP, Brazil, 14784-400
Fundacao Hospital Amaral Carvalho
Jau, SP, Brazil, 17210-120
Instituto de Oncologia de Piracicaba S/S Ltda.
Piracicaba, SP, Brazil, 13419-155
Centro de Referencia da Saude da Mulher
Sao Paulo, SP, Brazil, 01317-000
Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda.
Sao Paulo, SP, Brazil, 01317-001
France
CHRU Jean Minjoz
Besancon, France, 25030
Centre Leon Berard
LYON cedex 08, France, 69373
Institut Paoli Calmettes
Marseille, France, 13273 Cedex 9
Hopital Prive du Confluent
Nantes BP 20215, France, 44202 Cedex 2
Hopital Saint Louis
Paris, France, 75010
Hopital Tenon
Paris, France, 75020
Institut de Cancerologie de l'Ouest - Site Rene Gauducheau
Saint Herblain, France, 44805 Cedex
Hopitaux Universitaires de Strasbourg - Hopital Civil
Strasbourg, France, 67091Cedex
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, France, 31059 Cedex 9
CHU Bretonneau Centre Henry Kaplan
Tours Cedex 9, France, 37044
Institut Gustave Roussy
Villejuif Cedex, France, 94805
Germany
Universitaetsklinikum Erlangen
Erlangen, Bavaria, Germany, 91054
Medizinisches Zentrum fur Hamatologie und Onkologie Munchen MVZ
Munich, Bavaria, Germany, 80639
Radiologicum
Munich, Bavaria, Germany, 81331
IOZ Muenchen
Munich, Bavaria, Germany, 81377
University of Munich (LMU), Grosshadern Hospital
Munich, Bavaria, Germany, 81377
Radiologicum
Munich, Bavaria, Germany, 81539
Universitatsklinikum Carl Gustav Carus an der Technischen Univesitat Dresden
Dresden, Saxony, Germany, 01307
Ueberoertliche Radiologische Gemeinschaftspraxis
Dresden, Saxony, Germany, 01309
HELIOS Klinikum Berlin-Buch
Berlin, Germany, 13125
Praxisklinik Krebsheilkunde fuer Frauen/Brustzentrum
Berlin, Germany, 13595
University Hospital Duesseldorf
Duesseldorf, Germany, 40225
Kliniken Essen-Mitte, Klinik fur Senologie / Brustzentrum
Essen, Germany, 45136
Universitaetsklinikum Freiburg, Klinik fuer Frauenheilkunde
Freiburg, Germany, 79106
Oncologie Unter Ems
Leer, Germany, 26789
Klinikum rechts der Isar, TUM, Frauenklinik und Poliklinik
Munich, Germany, 81675
Unifrauenklinik am Klinikum Südstadt
Rostock, Germany, 18059
Universitaetsfrauenklinik
Ulm, Germany, 89075
Ireland
St. Vincent's University Hospital
Dublin 4, Ireland
Mater Misericordiae University Hospital
Dublin 7, Ireland
University Hospital Galway
Galway, Ireland
Israel
Soroka University Medical Center
Beer Sheva, Israel, 84101
Oncology Institute, Rambam Health Care Campus
Haifa, Israel, 31096
Oncology Institute, Davidoff Center, Rabin Medical Center, Beilinson Campus
Petach Tikva, Israel, 49100
Division of Oncology Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
The Chaim sheba Medical Center
Tel Hashomer, Israel, 5265601
Oncology Institute
Tel-Aviv, Israel, 69710
Assaf Harofeh Medical Center
Zerifin, Israel, 70300
Italy
Azienda Ospendaliera S.G. Moscati
Avellino, LC, Italy, 83100
Ospedale Vito Fazzi
Lecce, LC, Italy, 73100
Ospedale San Raffaele
Milano, MI, Italy, 20132
IRCCS-Istituto Europeo di Oncologia (IEO)
Milano, MI, Italy, I-20141
A.S.S.T. Monza
Monza, Monza Brianza, Italy, I-20900
La Maddalena Clinic For Cancer University of Palermo
Palermo, PA, Italy, 90146
A.O.U. Pisana, DAI di Oncologia, dei trapianti e delle nuove tecnologie
Pisa, PI, Italy, I-56126
Ospendale Sant'Andrea
Roma, RM, Italy, 00189
Ospedale Mater Salutis
Legnago, VR, Italy, 37045
S.S.D. Oncologia Medica Addarii, A.0.U. di Bologna
Bologna, Italy, I-40138
Universita Campus Bio-Medico di Roma, Dipartimento Oncologia Medica
Roma, Italy, I-00128
Korea, Republic of
Seoul National University Bundang Hospital
Bundang-gu, Gyeonggi-do, Korea, Republic of, 13620
National Cancer Centre
Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
Ajou University Hospital
Suwon, Gyeonggi-do, Korea, Republic of, 16499
Kyungpook National University Chilgok Hospital
Daegu, Korea, Republic of, 41404
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 21565
Korea University Anam Hospital
Seoul, Korea, Republic of, 02841
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 03722
Asan Medical Center
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 06351
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 06591
Ewha Womans University Mokdong Hospital
Seoul, Korea, Republic of, 07985
Ulsan University Hospital
Ulsan, Korea, Republic of, 44033
Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, LODZ Province, Poland, 90-242
Centrum Diagnostyki Urazowej FANTOM
Lodz, LODZ Province, Poland, 91-520
SPZOZ Centralny Szpital Kliniczny Instytut Stomatologii UM w Lodzi, Zaklad Medycyny Nuklearnej
Lodz, LODZ Province, Poland, 92-213
NZOZ Innowacyjna Medycyna
Dobra, Poland, 72-003
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gdansk, Poland, 80-952
Uniwersyteckie Centrum Kliniczne, Zaklad Medycyny Nuklearnej
Gdansk, Poland, 80-952
Uniwersyteckie Centrum Kliniczne, Zaklad Radiologii
Gdansk, Poland, 80-952
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Oddzial w Gliwicach
Gliwice, Poland, 44-101
NU-MED Centrum Diagnostyki i Terapii Onkologicznej Katowice
Katowice, Poland, 40-514
Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu
Katowice, Poland, 40-514
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
Lublin, Poland, 20-090
Europejskie Centrum Zdrowia Otwock Szpital im.F.Chopina
Otwock, Poland, 05-400
Szpital Kliniczny im. Heliodora Swiecickiego
Poznan, Poland, 60-355
Szpital Kliniczny Przemienienia Panskiego
Poznan, Poland, 60-569
Szpital Kliniczny Przemienienia Panskiego
Poznan, Poland, 61-848
Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie,Zaklad Radiologii
Poznan, Poland, 61-866
Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
Poznan, Poland, 61-866
Oddzial Onkologii Klinicznej, Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie
Szczecin, Poland, 70-111
Pracownia Tomografii Komputerowej , Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie
Szczecin, Poland, 70-111
Pracownia Medycyny Nuklearnej, 109 Szpital Wojskowy z Przychodnia SP ZOZ
Szczecin, Poland, 70-965
Centrum Onkologii-lnstytut im. Marii Sklodowskiej-Curie
Warszawa, Poland, 02-781
Klinika Onkologii, Wojskowy lnstytut Medyczny
Warszawa, Poland, 04-141
Zaklad Medycyny Nuklearmej, Wojskowy lnstytut Medyczny
Warszawa, Poland, 04-141
Zaklad Radiologii Lekarskiej, Wojskowy Instytut Medyczny
Warszawa, Poland, 04-141
Russian Federation
Gbuz Lood
Vsevologhskiy, Leningrad Region, Russian Federation, 188663
State Budgetary Institution of Healthcare "Republican Oncology dispensary"'
Petrozavodsk, Russian Federation, 185002/185007
City Clinical Oncology Dispensary
St. Petersburg, Russian Federation, 197022
Spain
Hospital Nuestra Senora de Sonsoles(Complejo Asistencial de Avila)
Avila, Spain, 05004
Hospital Universitari Germans Trias i Pujol
Badalona Barcelona, Spain, 08916
Hospital del Mar
Barcelona, Spain, 08003
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clinic I Provincial
Barcelona, Spain, 08036
Consorcio Hospitalario Provincial de Castellon
Castellon, Spain, 12002
Complejo Hospitalario de Jaen
Jaen, Spain, 23007
Centro Oncologico de Galicia
La Coruna, Spain, 15009
Hospital Universitario de Canarias
La Laguna Santa Cruz De Tenerife, Spain, 38320
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, Spain, 25198
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Hospital Universitario Ramon Y Cajal
Madrid, Spain, 28034
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital Universitario Quiron Madrid
Pozuelo De Alarcon (Madrid), Spain, 28223
Corporacio Sanitaria Parc Tauli
Sabadell Barcelona, Spain, 08208
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41009
Taiwan
Changhua Christian Hospital
Changhua, Taiwan, 500
National Taiwan University Hospital
Taipei, Taiwan, 10002
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan, 112
Ukraine
Communal Institution "Krivorizhskiy Oncology Dispensary" of Dnipropetrovsk Regional Council
Kriviy Rig, Ukraine, 50048
Regional Municipal Institution "Sumy Regional Clinical Oncology Dispensary", Thoracic Department
Sumy, Ukraine, 40005
United Kingdom
Sarah Cannon Research Institute UK
London, England, United Kingdom, W1G 6AD
The Harley Street Clinic Molecular Imaging Centre
London, England, United Kingdom, W1G 7LJ
Pharmacy Department
London, England, United Kingdom, W1G 8HL
The Harley Street Clinic
London, England, United Kingdom, W1G 8PP
Nottingham University Hospitals
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Sussex Cancer Centre
Brighton, Sussex, United Kingdom, BN2 2BE
St James University Hospital
Leeds, United Kingdom, LS9 7TF
Impretial College Healthcare NHS Trust - Charing Cross Hospital
London, United Kingdom, W6 8RF
Cancer Research UK, Department of Medical Oncology
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Pfizer
Medivation, Inc.
Investigators
Study Director: Pfizer Pfizer CT.gov Call Center Pfizer

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01945775     History of Changes
Other Study ID Numbers: 673-301
C3441009 ( Other Identifier: Alias Study Number )
2013-002716-28 ( EudraCT Number )
U1111-1155-7579 ( Other Identifier: Universal Trial Number )
First Posted: September 19, 2013    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Keywords provided by Pfizer:
Breast cancer
BRCA mutation
PARP inhibitor
BRCA 1
BRCA 2

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Poly(ADP-ribose) Polymerase Inhibitors
Talazoparib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents