A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)
EMBRACA
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
4 other identifiers
interventional
431
16 countries
362
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2013
Longer than P75 for phase_3
362 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2013
CompletedFirst Posted
Study publicly available on registry
September 19, 2013
CompletedStudy Start
First participant enrolled
October 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2017
CompletedResults Posted
Study results publicly available
October 3, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2021
CompletedJanuary 20, 2022
December 1, 2021
3.9 years
September 11, 2013
September 5, 2018
December 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS): Independent Radiological Facility (IRF) Assessment
IRF assessed PFS was defined as time (in months) from randomization until the date of first documented radiologic progressive disease per response evaluation criteria in solid tumors (RECIST) version 1.1 or death from any cause, whichever occurs first. As per RECIST v1.1, progression defined as 1) for target lesions: at least a 20% increase in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), the absolute increase in the sum has to be at least 5 millimeter (mm); 2) for non-target lesions: unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions; 3) and/or appearance of one or more new lesions. The analysis was performed by Kaplan-Meier method.
Baseline until radiologic progressive disease or death due to any cause (up to maximum duration of 36.9 months)
Secondary Outcomes (8)
Percentage of Participants With Objective Response: Investigator Assessment
Baseline until radiologic progressive disease or death due to any cause (up to a maximum duration of 36.9 months)
Overall Survival (OS)
Baseline until death due to any cause or analysis cut-off, up to a maximum duration of 61.4 months
Trough Plasma Talazoparib Concentrations
Predose on Day 1 of Cycle 2, 3 and 4
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months
Number of Participants With Grade 3 or 4 Post-baseline Toxicities in Laboratory Parameters: Hematology
Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months.
- +3 more secondary outcomes
Other Outcomes (4)
Duration of Response (DOR): Investigator Assessment
From first documentation of CR or PR until disease progression or death due to any cause, whichever occurred first (up to 36.9 months)
Change From Baseline in Global Health Status/Quality of Life (QoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) at Average Duration Over Week 4 up to Week 160
Baseline, Week 4 up to Week 160
Time to Deterioration (TTD) in Global Health Status/Quality of Life (QOL)
Baseline up to a maximum duration of 36.9 months
- +1 more other outcomes
Study Arms (2)
talazoparib
EXPERIMENTALPatient will be randomized 2:1 to receive talazoparib oral capsules (1.0 mg) once daily for 21 continuous days
Physician's-Choice
ACTIVE COMPARATORCapecitabine, Eribulin, Gemcitabine or Vinorelbine
Interventions
Eligibility Criteria
You may qualify if:
- 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 may not qualify 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Medivation, Inc.collaborator
Study Sites (362)
Arizona Oncology Associates P.C. - NAHOA
Flagstaff, Arizona, 86001, United States
HonorHealth
Scottsdale, Arizona, 85258, United States
Virginia G. Piper Cancer Pharmacy
Scottsdale, Arizona, 85258, United States
Kaiser Permanente Medical Center Lab Drawing Station
Antioch, California, 94509, United States
Kaiser Permanente Medical Center Lab Drawing Station
Antioch, California, 94531, United States
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
Bakersfield, California, 93309, United States
Kaiser Permanente Medical Center Lab Drawing Station
Fairfield, California, 94533-6901, United States
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
Fullerton, California, 92835, United States
Kaiser Permanente Medical Center Lab Drawing Station
Gilroy, California, 95020, United States
Los Angeles Hematology Oncology Medical Group
Glendale, California, 91204, United States
Los Angeles Hematology Oncology Medical Group
Glendale, California, 91206, United States
Marin Specialty Care
Greenbrae, California, 94904, United States
Los Angeles Hematology Oncolgy Medical Group
Los Angeles, California, 90017, United States
Los Angeles Hematology Oncology Medical Group
Los Angeles, California, 90057, United States
Drug Management Only: UCLA West Medical Pharmacy, Attn:Steven L. Wong, Pharm.D.
Los Angeles, California, 90095-7349, United States
Drug Management only: UCLA West Medical Pharmacy
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
Los Angeles, California, 90095-7349, United States
UCLA West Medical Pharmacy, Attn:Steven L. Wong, Pharm.D.
Los Angeles, California, 90095-7349, United States
Regulatory Managment Only: TRIO-US Central Administration
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 West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.
Los Angeles, California, 90095, United States
University of California Los Angeles
Los Angeles, California, 90095, United States
Kaiser Permanente Medical Center Lab Drawing Station
Martinez, California, 94553, United States
Kaiser Permanente Medical Center Lab Drawing Station
Milpitas, California, 95035-5491, United States
Kaiser Permanente Medical Center Lab Drawing Station
Modesto, California, 95356, United States
Kaiser Permanente Medical Center Lab Drawing Station
Mountain View, California, 94041, United States
Kaiser Permanente Medical Center Lab Drawing Station
Napa, California, 94558-3313, United States
Kaiser Permanente Medical Center (clinic+DSL)
Oakland, California, 94611, United States
Kaiser Permanente Medical Center (Radiology)
Oakland, California, 94611, United States
Kaiser Permanente Medical Center Lab Drawing Station
Pleasanton, California, 94558, United States
Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer care Associates
Redondo Beach, California, 90277, United States
Kaiser Permanente Medical Center Lab Drawing Station
Redwood City, California, 94063, United States
Kaiser Permanente Medical Center (clinic+DSL)
Roseville, California, 95661, United States
Southern California Permanente Medical Group
San Diego, California, 92120, United States
UCSF - Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115, United States
UCSF Helen Diller Comprehensive Cancer Centre - Precision Cancer Medicine Building
San Francisco, California, 94158, United States
Kaiser Permanente Mission Bay Medical Center Lab Drawing Station
San Francisco, California, 94518, United States
Kaiser Permanente Medical Center Lab Drawing Station
San Jose, California, 95110, United States
Kaiser Permanente Medical Center (clinic+DSL)
San Leandro, California, 94577, United States
Pacific Central Coast Health Centers - San Luis Obispo Oncology and Hematology Health Center
San Luis Obispo, California, 93401, United States
Ridley Tree Cancer Center
Santa Barbara, California, 93105, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105, United States
Kaiser Permanente Medical Center (clinic+DSL)
Santa Clara, California, 95051, United States
Central Coast Medical Oncology Corporation
Santa Maria, California, 93454, United States
UCLA Hematology Oncology
Santa Monica, California, 90404, United States
UCLA Hematology/Oncology - Parkside
Santa Monica, California, 90404, United States
UCLA Santa Monica Medical Center & Orthopaedic Hospital
Santa Monica, California, 90404, United States
Sutter North Bay Health Plaza
Santa Rosa, California, 95403, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, 95403, United States
Sutter Santa Rosa Regional Hospital
Santa Rosa, California, 95403, United States
Ridley Tree Cancer Center
Solvang, California, 93463, United States
Kaiser Permanente Medical Center (clinic+DSL)
South San Francisco, California, 94080, United States
Stanford Cancer Institute
Stanford, California, 94305, United States
Stanford Women's Cancer Center
Stanford, California, 94305, United States
UCLA Hematology/Oncology - Santa Clarita
Valencia, California, 91355, United States
Kaiser Permanente Medical Center (clinic+DSL)
Vallejo, California, 94589, United States
Kaiser Permanente Medical Center (clinic+DSL)
Walnut Creek, California, 94596, United States
Southern California Permanente Medical Group
Woodland Hills, California, 91367, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, 80045, United States
Rocky Mountain Cancer Centers
Boulder, Colorado, 80303, United States
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80220, United States
Rocky Mountain Cancer Centers
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers
Littleton, Colorado, 80120-4413, United States
Rocky Mountain Cancer Centers
Lone Tree, Colorado, 80124, United States
Rocky Mountain Cancer Centers
Longmont, Colorado, 80501, United States
Rocky Mountain Cancer Centers
Parker, Colorado, 80138, United States
Rocky Mountain Cancer Centers
Pueblo, Colorado, 81008, United States
Rocky Mountain Cancer Centers
Thornton, Colorado, 80260, United States
Cancer Center of Central Connecticut
Plainville, Connecticut, 06062, United States
Florida Cancer Specialists
Altamonte Springs, Florida, 32701, United States
Florida Cancer Specialists
Brandon, Florida, 33511, United States
Florida Cancer Specialists
Clearwater, Florida, 33761, United States
Sylvester Comprehensive Cancer Center Deerfield Beach
Deerfield Beach, Florida, 33442, United States
Florida Cancer Specialists
Gainesville, Florida, 32605, United States
Memorial Healthcare System
Hollywood, Florida, 33021, United States
Memorial Regional Hospital
Hollywood, Florida, 33021, United States
Florida Cancer Specialists
Hudson, Florida, 34667, United States
Cancer Specialists of North Florida
Jacksonville, Florida, 32003, United States
Cancer Specialists of North Florida
Jacksonville, Florida, 32204, United States
Cancer Specialists of North Florida
Jacksonville, Florida, 32207, United States
Cancer Specialists of North Florida
Jacksonville, Florida, 32256, United States
Cancer Specialists of North Florida
Jacksonville, Florida, 32258, United States
Cancer Specialists of North Florida
Jacksonville Beach, Florida, 32250, United States
Florida Cancer Specialists
Lady Lake, Florida, 32159, United States
Florida Cancer Specialists
Largo, Florida, 33770, United States
Florida Cancer Specialists
Lecanto, Florida, 34461, United States
"University of Miami Hospital & Clinics,Sylvester Comprehensive Cancer Center/UMHC"
Miami, Florida, 33136, United States
Sylvester Comprehensive Cancer Center Kendall
Miami, Florida, 33176, United States
Florida Cancer Specialists
New Port Richey, Florida, 34655, United States
Florida Cancer Specialists
Orange City, Florida, 32763, United States
Florida Cancer Specialists
Orlando, Florida, 32806, United States
Orlando Health, Inc
Orlando, Florida, 32806, United States
Sylvester Comprehensive Cancer Center Plantation
Plantation, Florida, 33324, United States
Cancer Specialists of North Florida
Saint Augustine, Florida, 32086, United States
Florida Cancer Specialists
Spring Hill, Florida, 34608, United States
Florida Cancer Specialists
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists
Tampa, Florida, 33607, United States
Florida Cancer Specialists
Tavares, Florida, 32778, United States
Central Georgia Cancer Care, PC
Macon, Georgia, 31201, United States
Central Georgia Cancer Care, PC
Warner Robins, Georgia, 31088-2259, United States
Indiana University- Melvin and Bren Simon Cancer Center (IUSCC)
Indianapolis, Indiana, 46202, United States
IU Health University Hospital
Indianapolis, Indiana, 46202, United States
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, 46202, United States
Springmill Medical Clinic
Indianapolis, Indiana, 46290, United States
The University of Kansas Cancer Center (Regulatory Office)
Fairway, Kansas, 66205, United States
The University of Kansas Cancer Center
Kansas City, Kansas, 66112, United States
The University of Kansas Cancer Center
Overland Park, Kansas, 66210, United States
The University of Kansas Cancer Center - Investigational Drug Services
Westwood, Kansas, 66205, United States
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Cancer And Hematology Centers Of Western Michigan
Grand Rapids, Michigan, 49506, United States
Minnesota Oncology Hematology, P.A.
Coon Rapids, Minnesota, 55433, United States
Minnesota Oncology Hematology, P.A.
Edina, Minnesota, 55435-2150, United States
Minnesota Oncology Hematology, P.A.
Fridley, Minnesota, 55432, United States
Minnesota Oncology Hematology, P.A.
Maplewood, Minnesota, 55109, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404, United States
Minnesota Oncology Hematology, P.A.
Saint Paul, Minnesota, 55102-2389, United States
Minnesota Oncology Hematology, P.A.
Woodbury, Minnesota, 55125, United States
The West Clinic, P.C.
Corinth, Mississippi, 38834, United States
The West Clinic, P.C. d/b/a West Cancer Center
Southaven, Mississippi, 38671, United States
The University of Kansas Cancer Center
Kansas City, Missouri, 64131, United States
The University of Kansas Cancer Center
Kansas City, Missouri, 64154, United States
The University of Kansas Cancer Center
Lee's Summit, Missouri, 64064, United States
Comprehensive Cancer Centers Of Nevada
Henderson, Nevada, 89052, United States
New York Oncology Hematology, P.C.
Albany, New York, 12208, United States
New York Oncology Hematology, P.C.
Clifton Park, New York, 12065, United States
New York University Langone Medical Center
New York, New York, 10016, United States
Perlmutter Cancer Center
New York, New York, 10016, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, 10021, United States
Weill Cornell Medical College - New York-Presbyterian Hospital
New York, New York, 10021, United States
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, 10065, United States
Weill Cornell Breast Center
New York, New York, 10065, United States
Weill Cornell Medical Center
New York, New York, 10065, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, 10065, United States
Eastchester Center for Cancer Care
The Bronx, New York, 10469, United States
Hope Women's Cancer Centers
Asheville, North Carolina, 28806, United States
MH Mission Hospital, LLLP
Asheville, North Carolina, 28806, United States
Novant Health Cancer Specialists
Charlotte, North Carolina, 28204, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
Southern Oncology Specialists
Charlotte, North Carolina, 28262, United States
Lake Norman Hematology Oncology Specialists
Huntersville, North Carolina, 28078, United States
Novant Health Huntersville Medical Center
Huntersville, North Carolina, 28078, United States
Southern Oncology Specialists
Huntersville, North Carolina, 28078, United States
Novant Health Cancer Specialists
Matthews, North Carolina, 28105, United States
Novant Health Matthews Medical Center
Matthews, North Carolina, 28105, United States
Lake Norman Hematology Oncology Specialists
Mooresville, North Carolina, 28117, United States
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, 74146, United States
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97213, United States
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97227, United States
Northwest Cancer Specialists, P.C.
Tigard, Oregon, 97223, United States
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505, United States
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213, United States
University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Tennessee Oncology, PLLC
Dickson, Tennessee, 37055, United States
Tennessee Oncology, PLLC
Franklin, Tennessee, 37067, United States
Tennessee Oncology PLLC
Gallatin, Tennessee, 37066, United States
The West Clinic, P.C. d/b/a West Cancer Center
Germantown, Tennessee, 38138, United States
Tennessee Oncology, PLLC
Hermitage, Tennessee, 37076, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Tennessee Oncology, PLLC
Lebanon, Tennessee, 37090, United States
The West Clinic, P.C. d/b/a West Cancer Center
Memphis, Tennessee, 38104, United States
Tennessee Oncology PLLC
Murfreesboro, Tennessee, 37129, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Tennessee Oncology PLLC
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203, United States
Tennessee Oncology PLLC
Nashville, Tennessee, 37205, United States
Tennessee Oncology PLLC
Nashville, Tennessee, 37207, United States
Tennessee Oncology PLLC
Nashville, Tennessee, 37211, United States
Tennessee Oncology, PLLC
Shelbyville, Tennessee, 37160, United States
Tennessee Oncology PLLC
Smyrna, Tennessee, 37167, United States
The Center for Cancer and Blood Disorders
Arlington, Texas, 76014, United States
Texas Oncology-South Austin
Austin, Texas, 78745, United States
The Center for Cancer and Blood Disorders (Huguley)
Burleson, Texas, 76028, United States
Texas Oncology - Cedar Park
Cedar Park, Texas, 78613, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology-El Paso Cancer Treatment Center Grandview
El Paso, Texas, 79902, United States
Texas Oncology-El Paso Cancer Treatment Center Gateway
El Paso, Texas, 79915, United States
Texas Oncology - El Paso Cancer Treatment Center Joe Battle
El Paso, Texas, 79938, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104, United States
Investigational Products Center (IPC)
Fort Worth, Texas, 76177, United States
Texas Oncology-Memorial City
Houston, Texas, 77024, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
University Of Texas, Md Anderson Cancer Center
Houston, Texas, 77030, United States
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
US Oncology Investigational Product Center (IPC)
Irving, Texas, 75063, United States
US Oncology Investigational Products Center (IPC)
Irving, Texas, 75063, United States
US Oncology Investigational Products Center(IPC)
Irving, Texas, 75063, United States
Texas Oncology-Plano East
Plano, Texas, 75075-7787, United States
Texas Oncology-Seton Williamson
Round Rock, Texas, 78665, United States
Texas Oncology - Waco
Waco, Texas, 76712, United States
Texas Oncology-Waco
Waco, Texas, 76712, United States
The Center for Cancer and Blood Disorders
Weatherford, Texas, 76086, United States
Virginia Cancer Specialists, PC
Alexandria, Virginia, 22304, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Newport News, Virginia, 23606, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Virginia Oncology Associates
Virginia Beach, Virginia, 23456, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
Northwest Cancer Specialists, P.C.(Admin Only)
Vancouver, Washington, 98683, United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684, United States
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
ICON Cancer Care (Haematology And Oncology Clinics Of Australasia (Hoca))-Milton
Milton, Queensland, 4064, Australia
Icon Cancer Care, Corporate Office
South Brisbane, Queensland, 4101, Australia
ICON Cancer Care
South Brisbane, Queensland, 4101, Australia
ICON Cancer Foundation
South Brisbane, Queensland, 4101, Australia
Mater Adult Hospital
South Brisbane, Queensland, 4101, Australia
Icon Cancer Care South Brisbane
South Brisbane, Queensland, 4104, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Adelaide Cancer Centre
Kurralta Park, South Australia, 5037, Australia
Ashford Cancer Centre Research
Kurralta Park, South Australia, 5037, Australia
Cancer Care SA PTY Ltd
Kurralta Park, South Australia, 5037, Australia
Cancer Care SA trading as Icon Pharmacy Adelaide
Kurralta Park, South Australia, 5037, Australia
Victoria Breast and Oncology Care
East Melbourne, Victoria, 3002, Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, 3199, Australia
Barwon Health, University Hospital Geelong
Geelong, Victoria, 3220, Australia
Austin Health, Heidelberg Repatriation Hospital (radiology (MUGA)scans only)
Heidelberg West, Victoria, 3081, Australia
Austin Health, The Austin Hospital
Melbourne, Victoria, 3084, Australia
Slade Pharmacy Mount Waverley
Mount Waverley, Victoria, 3149, Australia
Nova Pharmacy
Wendouree, Victoria, 3353, Australia
Ballarat Oncology & Haematology Services Clinical Trials Unit
Wendouree, Victoria, 3355, Australia
Ballarat Oncology & Haematology Services
Wendouree, Victoria, 3355, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Sir Charles Gairdner Hospital Lung Institute Of Western Australia
Nedlands, Western Australia, 6009, Australia
River City Pharmacy
Auchenflower, 4066, Australia
Icon Cancer Care
Milton, 4066, Australia
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
CHU Sart Tilman Liege
Liège, B-4000, Belgium
Instituto Nacional do Cancer Jose de Alencar Gomes da Silva
Rio de Janeiro, Rio de Janeiro, 20230-130, Brazil
Central de Quimioterapia Hospital do Cancer-INCA-HCIII
Rio de Janeiro, Rio de Janeiro, 20560-120, Brazil
Hospital do Cancer III - INCA / Instituto Nacional do Cancer / MS INCA HCIII
Rio de Janeiro, Rio de Janeiro, 20560-120, Brazil
Hopital da Cidade de Passo Fundo
Passo Fundo, Rio Grande do Sul, 99010-260, Brazil
Hospital da Cidade de Passo Fundo - HCPF
Passo Fundo, Rio Grande do Sul, 99010-260, Brazil
Associacao Hospitalar Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-001, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Uniao Brasileira de Educacao E Assistencia
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Hospital do Cancer de Barretos - Fundacao Pio XII
Barretos, São Paulo, 14784-400, Brazil
Fundacao Hospital Amaral Carvalho
Jaú, São Paulo, 17210-120, Brazil
Instituto de Oncologia de Piracicaba S/S Ltda.
Piracicaba, São Paulo, 13419-155, Brazil
Centro de Referencia da Saude da Mulher - Hospital Perola Byington
São Paulo, São Paulo, 01317-000, Brazil
Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamária Ltda.
São Paulo, São Paulo, 01317-001, Brazil
CHRU Jean Minjoz
Besançon, 25030, France
Centre Leon Berard
Lyon, 69373, France
Institut Paoli Calmettes
Marseille, 13273 Cedex 9, France
Hopital Prive du Confluent
Nantes BP 20215, 44202 Cedex 2, France
Hopital Saint Louis
Paris, 75010, France
Hopital Tenon
Paris, 75020, France
Institut de Cancerologie de l'Ouest - Site Rene Gauducheau
Saint-Herblain, 44805 Cedex, France
Hopitaux Universitaires de Strasbourg - Hopital Civil
Strasbourg, 67200, France
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, 31059 Cedex 9, France
CHU Bretonneau Centre Henry Kaplan
Tours, 37044, France
Institut Gustave Roussy
Villejuif, 94805, France
Medizinisches Zentrum fur Hamatologie und Onkologie Munchen MVZ
Munich, Bavaria, 80639, Germany
Radiologicum
Munich, Bavaria, 81331, Germany
IOZ Muenchen
Munich, Bavaria, 81377, Germany
University of Munich (LMU), Grosshadern Hospital
Munich, Bavaria, 81377, Germany
Radiologicum
Munich, Bavaria, 81539, Germany
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden
Dresden, Saxony, 01307, Germany
HELIOS Klinikum Berlin-Buch
Berlin, 13125, Germany
Praxisklinik Krebsheilkunde fuer Frauen/Brustzentrum
Berlin, 13595, Germany
University Hospital Duesseldorf
Düsseldorf, 40225, Germany
Universitaetsklinikum Erlangen
Erlangen, 91054, Germany
Kliniken Essen-Mitte, Klinik für Senologie / Brustzentrum
Essen, 45136, Germany
Universitaetsklinikum Freiburg, Klinik fuer Frauenheilunde
Freiburg im Breisgau, 79106, Germany
Oncologie Unter Ems
Leer, 26789, Germany
Klinikum rechts der Isar, TUM, Frauenklinik und Poliklinik
Munich, 81675, Germany
Unifrauenklinik am Klinikum Suedstadt
Rostock, 18059, Germany
Universitaetsfrauenklinik
Ulm, 89075, Germany
Mater Misericordiae University Hospital
Dublin, Ireland
St. Vincent's University Hospital
Dublin, Ireland
University Hospital Galway
Galway, Ireland
Soroka University Medical Center
Beersheba, 84101, Israel
Oncology Institute, Rambam Health Care Campus
Haifa, 31096, Israel
Oncology Institute, Davidoff Center, Rabin Medical Center, Beilinson Campus
Petah Tikva, 49100, Israel
Division of Oncology Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Assuta Medical Center
Tel Aviv, 69710, Israel
Oncology Institute, Assuta Medical Center
Tel Aviv, 69710, Israel
The Chaim sheba Medical Center
Tel Litwinsky, 5265601, Israel
Assaf Harofeh Medical Center
Ẕerifin, 70300, Israel
A.O.S.G. Moscati - Contrada Amoretta
Avellino, AV, 83100, Italy
Ospedale S. Raffaelle di Milano
Milan, MI, 20132, Italy
A.S.S.T. Monza
Monza, Monza and Brianza, I-20900, Italy
A.S.S.T. Monza, Oncologia Medica, Ospedale San Gerardo
Monza, Monza Brianza, I-20900, Italy
La Maddalena Clinic For Cancer University Of Palermo
Palermo, PA, 90146, Italy
A.O.U. Pisana, DAI Oncologia, U.O. Oncologia Med. 2 Univ.
Pisa, PI, I-56126, Italy
Ospendale Sant'Andrea
Roma, RM, 00189, Italy
Ospedale Mater Salutis
Legnago, VR, 37045, Italy
S.S.D. Oncologia Medica Addarii - A.O.U. di Bologna - Policlinico Sant'Orsola-Malpighi
Bologna, 1-40138, Italy
Senologia Medica, IRCCS-Instituto Oncologico Europeo (IEO)
Milan, I-20141, Italy
Universita Campus Bio-Medico di Roma, Dipartimento Oncologia Medica
Roma, I-00128, Italy
Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, LODZ Province, 90-242, Poland
NZOZ Innowacyjna Medycyna
Dobra, 72-003, Poland
Uniwersyteckie Centrum Kliniczne, Zaklad Medycyny Nuklearnej
Gdansk, 80-211, Poland
Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii
Gdansk, 80-952, Poland
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gdansk, 80-952, Poland
Uniwersyteckie Centrum Kliniczne, Zaklad Radiologii
Gdansk, 80-952, Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Oddzial w Gliwicach
Gliwice, 44-101, Poland
NU-MED Centrum Diagnostyki i Terapii Onkologicznej Katowice
Katowice, 40-514, Poland
Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu
Katowice, 40-514, Poland
Europejskie Centrum Zdrowia Otwock Szpital im.F.Chopina
Otwock, 05-400, Poland
Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
Poznan, 60-355, Poland
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Pozna
Poznan, 60-569, Poland
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola
Poznan, 60-569, Poland
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Pozna
Poznan, 61-848, Poland
Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
Poznan, 61-866, Poland
Oddzial Onkologii Klinicznej, Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie
Szczecin, 70-111, Poland
Pracownia Tomografii Komputerowej , Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie
Szczecin, 70-111, Poland
Pracownia Medycyny Nuklearnej, 109 Szpital Wojskowy z Przychodnia SP ZOZ
Szczecin, 70-965, Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Nowotworow Piersi i
Warsaw, 02-781, Poland
Klinika Onkologii, Wojskowy lnstytut Medyczny
Warsaw, 04-141, Poland
Gbuz Lood
Leningrad, Leningradskaya Oblast', 188663, Russia
State Budgetary Institution of Healthcare "Republican Oncology dispensary"'
Petrozavodsk, 185002/185007, Russia
City Clinical Oncology Dispensary
Saint Petersburg, 197022, Russia
Seoul National University Bundang Hospital
Bundang-gu, Gyeonggi-do, 13620, South Korea
National Cancer Centre
Goyang-si, Gyeonggi-do, 10408, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, 16499, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Ewha Womans University Mokdong Hospital
Seoul, 07985, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Ulsan University Hospital
Ulsan, 44033, South Korea
Centro Oncologico de Galicia
A Coruña, 15009, Spain
Hospital Nuestra Senora de Sonsoles(Complejo Asistencial de Avila)
Ávila, 05004, Spain
Hospital Universitari Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clinic I Provincial
Barcelona, 08036, Spain
Consorcio Hospitalario Provincial de Castellon
Castellon, 12002, Spain
Complejo Hospitalario de Jaen
Jaén, 23007, Spain
Hospital Universitario de Canarias
La Laguna Santa Cruz de Tenerife, 38320, Spain
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, 25198, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario Quiron Madrid
Pozuelo de Alarcon (Madrid), 28223, Spain
Corporacio Sanitaria Parc Tauli
Sabadell Barcelona, 08208, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Changhua Christian Hospital
Changhua, 500, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 112, Taiwan
Communal Institution "Krivorizhskiy Oncology Dispensary" of Dnipropetrovsk Regional Council
Kryvyi Rih, 50048, Ukraine
Regional Municipal Institution "Sumy Regional Clinical Oncology Dispensary", Thoracic Department
Sumy, 40005, Ukraine
Sarah Cannon Research Institute UK
London, England, W1G 6AD, United Kingdom
Nottingham University Hospital NHS Trust
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
Royal Sussex County Hospital, Royal Alexandra Children's Hospital L10
Brighton, BN2 2BE, United Kingdom
St James University Hospital
Leeds, LS9 7TF, United Kingdom
Impretial College Healthcare NHS Trust
London, W6 8RF, United Kingdom
Cancer Research UK, Department of Medical Oncology - The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Related Publications (3)
Blum JL, Laird AD, Litton JK, Rugo HS, Ettl J, Hurvitz SA, Martin M, Roche HH, Lee KH, Goodwin A, Chen Y, Lanzalone S, Chelliserry J, Czibere A, Hopkins JF, Albacker LA, Mina LA. Determinants of Response to Talazoparib in Patients with HER2-Negative, Germline BRCA1/2-Mutated Breast Cancer. Clin Cancer Res. 2022 Apr 1;28(7):1383-1390. doi: 10.1158/1078-0432.CCR-21-2080.
PMID: 35091441DERIVEDEttl J, Quek RGW, Lee KH, Rugo HS, Hurvitz S, Goncalves A, Fehrenbacher L, Yerushalmi R, Mina LA, Martin M, Roche H, Im YH, Markova D, Bhattacharyya H, Hannah AL, Eiermann W, Blum JL, Litton JK. Quality of life with talazoparib versus physician's choice of chemotherapy in patients with advanced breast cancer and germline BRCA1/2 mutation: patient-reported outcomes from the EMBRACA phase III trial. Ann Oncol. 2018 Sep 1;29(9):1939-1947. doi: 10.1093/annonc/mdy257.
PMID: 30124753DERIVEDLitton JK, Rugo HS, Ettl J, Hurvitz SA, Goncalves A, Lee KH, Fehrenbacher L, Yerushalmi R, Mina LA, Martin M, Roche H, Im YH, Quek RGW, Markova D, Tudor IC, Hannah AL, Eiermann W, Blum JL. Talazoparib in Patients with Advanced Breast Cancer and a Germline BRCA Mutation. N Engl J Med. 2018 Aug 23;379(8):753-763. doi: 10.1056/NEJMoa1802905. Epub 2018 Aug 15.
PMID: 30110579DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2013
First Posted
September 19, 2013
Study Start
October 14, 2013
Primary Completion
September 15, 2017
Study Completion
March 5, 2021
Last Updated
January 20, 2022
Results First Posted
October 3, 2018
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.