Clinical trial NCT01945775: A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Neoplasms
BRCA 1 Gene Mutation
BRCA 2 Gene Mutation
Keywords: Breast cancer
BRCA mutation
PARP inhibitor
BRCA 1
BRCA 2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Medivation, Inc.
First posted: 2013-09-19
Enrollment: 431
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Progression-Free Survival (PFS): Independent Radiological Facility (IRF) Assessment
timeFrame: Baseline until radiologic progressive disease or death due to any cause (up to maximum duration of 36.9 months)
Secondary outcomes:
measure: Percentage of Participants With Objective Response: Investigator Assessment
timeFrame: Baseline until radiologic progressive disease or death due to any cause (up to a maximum duration of 36.9 months)
measure: Overall Survival (OS)
timeFrame: Baseline until death due to any cause or analysis cut-off, up to a maximum duration of 61.4 months
measure: Trough Plasma Talazoparib Concentrations
timeFrame: Predose on Day 1 of Cycle 2, 3 and 4
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months
measure: Number of Participants With Grade 3 or 4 Post-baseline Toxicities in Laboratory Parameters: Hematology
timeFrame: Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months.
measure: Number of Participants With Grade 3 or 4 Post-baseline Toxicities in Laboratory Parameters: Chemistry
timeFrame: Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months
measure: Number of Participants With Potentially Clinically Significant Changes From Baseline in Vital Signs
timeFrame: Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months
measure: Number of Participants Taking At-least One Concomitant Medication
timeFrame: Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months
Other outcomes:
measure: Duration of Response (DOR): Investigator Assessment
timeFrame: From first documentation of CR or PR until disease progression or death due to any cause, whichever occurred first (up to 36.9 months)
measure: 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
timeFrame: Baseline, Week 4 up to Week 160
measure: Time to Deterioration (TTD) in Global Health Status/Quality of Life (QOL)
timeFrame: Baseline up to a maximum duration of 36.9 months
measure: Time to Deterioration (TTD) in Breast Symptoms Scale as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC-QLQ-BR23)
timeFrame: Baseline up to a maximum duration of 36.9 months
Locations:
city: Flagstaff
country: United States
facility: Arizona Oncology Associates P.C. - NAHOA
state: Arizona
city: Scottsdale
country: United States
facility: HonorHealth
state: Arizona
city: Scottsdale
country: United States
facility: Virginia G. Piper Cancer Pharmacy
state: Arizona
city: Antioch
country: United States
facility: Kaiser Permanente Medical Center Lab Drawing Station
state: California
city: Antioch
country: United States
facility: Kaiser Permanente Medical Center Lab Drawing Station
state: California
city: Bakersfield
country: United States
facility: CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
state: California
city: Fairfield
country: United States
facility: Kaiser Permanente Medical Center Lab Drawing Station
state: California
city: Fullerton
country: United States
facility: St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
state: California
city: Gilroy
country: United States
facility: Kaiser Permanente Medical Center Lab Drawing Station
state: California
city: Glendale
country: United States
facility: Los Angeles Hematology Oncology Medical Group
state: California
city: Glendale
country: United States
facility: Los Angeles Hematology Oncology Medical Group
state: California
city: Greenbrae
country: United States
facility: Marin Specialty Care
state: California
city: Los Angeles
country: United States
facility: Los Angeles Hematology Oncolgy Medical Group
state: California
city: Los Angeles
country: United States
facility: Los Angeles Hematology Oncology Medical Group
state: California
city: Los Angeles
country: United States
facility: Drug Management Only: UCLA West Medical Pharmacy, Attn:Steven L. Wong, Pharm.D.
state: California
city: Los Angeles
country: United States
facility: Drug Management only: UCLA West Medical Pharmacy
state: California
city: Los Angeles
country: United States
facility: UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm. D.
state: California
city: Los Angeles
country: United States
facility: UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.
state: California
city: Los Angeles
country: United States
facility: UCLA West Medical Pharmacy, Attn: Steven L. Wong
state: California
city: Los Angeles
country: United States
facility: UCLA West Medical Pharmacy, Attn:Steven L. Wong, Pharm.D.
state: California
city: Los Angeles
country: United States
facility: Regulatory Managment Only: TRIO-US Central Administration
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: TRIO-US Central Administration
state: California
city: Los Angeles
country: United States
facility: UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Martinez
country: United States
facility: Kaiser Permanente Medical Center Lab Drawing Station
state: California
city: Milpitas
country: United States
facility: Kaiser Permanente Medical Center Lab Drawing Station
state: California
city: Modesto
country: United States
facility: Kaiser Permanente Medical Center Lab Drawing Station
state: California
city: Mountain View
country: United States
facility: Kaiser Permanente Medical Center Lab Drawing Station
state: California
city: Napa
country: United States
facility: Kaiser Permanente Medical Center Lab Drawing Station
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Medical Center (clinic+DSL)
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Medical Center (Radiology)
state: California
city: Pleasanton
country: United States
facility: Kaiser Permanente Medical Center Lab Drawing Station
state: California
city: Redondo Beach
country: United States
facility: Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer care Associates
state: California
city: Redwood City
country: United States
facility: Kaiser Permanente Medical Center Lab Drawing Station
state: California
city: Roseville
country: United States
facility: Kaiser Permanente Medical Center (clinic+DSL)
state: California
city: San Diego
country: United States
facility: Southern California Permanente Medical Group
state: California
city: San Francisco
country: United States
facility: UCSF - Helen Diller Family Comprehensive Cancer Center
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Comprehensive Cancer Centre - Precision Cancer Medicine Building
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Mission Bay Medical Center Lab Drawing Station
state: California
city: San Jose
country: United States
facility: Kaiser Permanente Medical Center Lab Drawing Station
state: California
city: San Leandro
country: United States
facility: Kaiser Permanente Medical Center (clinic+DSL)
state: California
city: San Luis Obispo
country: United States
facility: Pacific Central Coast Health Centers - San Luis Obispo Oncology and Hematology Health Center
state: California
city: Santa Barbara
country: United States
facility: Ridley Tree Cancer Center
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Medical Center (clinic+DSL)
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology Corporation
state: California
city: Santa Monica
country: United States
facility: UCLA Hematology Oncology
state: California
city: Santa Monica
country: United States
facility: UCLA Hematology/Oncology - Parkside
state: California
city: Santa Monica
country: United States
facility: UCLA Santa Monica Medical Center & Orthopaedic Hospital
state: California
city: Santa Rosa
country: United States
facility: Sutter North Bay Health Plaza
state: California
city: Santa Rosa
country: United States
facility: Sutter Pacific Medical Foundation
state: California
city: Santa Rosa
country: United States
facility: Sutter Santa Rosa Regional Hospital
state: California
city: Solvang
country: United States
facility: Ridley Tree Cancer Center
state: California
city: South San Francisco
country: United States
facility: Kaiser Permanente Medical Center (clinic+DSL)
state: California
city: Stanford
country: United States
facility: Stanford Cancer Institute
state: California
city: Stanford
country: United States
facility: Stanford Women's Cancer Center
state: California
city: Valencia
country: United States
facility: UCLA Hematology/Oncology - Santa Clarita
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Medical Center (clinic+DSL)
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente Medical Center (clinic+DSL)
state: California
city: Woodland Hills
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Cancer Center - Anschutz Cancer Pavilion (ACP)
state: Colorado
city: Boulder
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Colorado Springs
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Lakewood
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Littleton
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Longmont
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Parker
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Pueblo
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Thornton
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Plainville
country: United States
facility: Cancer Center of Central Connecticut
state: Connecticut
city: Altamonte Springs
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Brandon
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Clearwater
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Deerfield Beach
country: United States
facility: Sylvester Comprehensive Cancer Center Deerfield Beach
state: Florida
city: Gainesville
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Hudson
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Jacksonville Beach
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Lady Lake
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Largo
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Lecanto
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Miami
country: United States
facility: "University of Miami Hospital & Clinics,Sylvester Comprehensive Cancer Center/UMHC"
state: Florida
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center Kendall
state: Florida
city: New Port Richey
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Orange City
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Orlando
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Orlando
country: United States
facility: Orlando Health, Inc
state: Florida
city: Plantation
country: United States
facility: Sylvester Comprehensive Cancer Center Plantation
state: Florida
city: Saint Augustine
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Spring Hill
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Tampa
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Tavares
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Macon
country: United States
facility: Central Georgia Cancer Care, PC
state: Georgia
city: Warner Robins
country: United States
facility: Central Georgia Cancer Care, PC
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University- Melvin and Bren Simon Cancer Center (IUSCC)
state: Indiana
city: Indianapolis
country: United States
facility: IU Health University Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Sidney and Lois Eskenazi Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Springmill Medical Clinic
state: Indiana
city: Fairway
country: United States
facility: The University of Kansas Cancer Center (Regulatory Office)
state: Kansas
city: Kansas City
country: United States
facility: The University of Kansas Cancer Center
state: Kansas
city: Overland Park
country: United States
facility: The University of Kansas Cancer Center
state: Kansas
city: Westwood
country: United States
facility: The University of Kansas Cancer Center - Investigational Drug Services
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland, Greenebaum Comprehensive Cancer Center
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer And Hematology Centers Of Western Michigan
state: Michigan
city: Coon Rapids
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Edina
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Fridley
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Maplewood
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Saint Paul
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Woodbury
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Corinth
country: United States
facility: The West Clinic, P.C.
state: Mississippi
city: Southaven
country: United States
facility: The West Clinic, P.C. d/b/a West Cancer Center
state: Mississippi
city: Kansas City
country: United States
facility: The University of Kansas Cancer Center
state: Missouri
city: Kansas City
country: United States
facility: The University of Kansas Cancer Center
state: Missouri
city: Lee's Summit
country: United States
facility: The University of Kansas Cancer Center
state: Missouri
city: Henderson
country: United States
facility: Comprehensive Cancer Centers Of Nevada
state: Nevada
city: Albany
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: Bronx
country: United States
facility: Eastchester Center for Cancer Care
state: New York
city: Clifton Park
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
city: New York
country: United States
facility: Perlmutter Cancer Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College - New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College - New York-Presbyterian Hospital
state: New York
city: New York
country: United States
facility: New York-Presbyterian Hospital/Weill Cornell Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Breast Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College - New York Presbyterian Hospital
state: New York
city: Asheville
country: United States
facility: Hope Women's Cancer Centers
state: North Carolina
city: Asheville
country: United States
facility: MH Mission Hospital, LLLP
state: North Carolina
city: Charlotte
country: United States
facility: Novant Health Cancer Specialists
state: North Carolina
city: Charlotte
country: United States
facility: Novant Health Presbyterian Medical Center
state: North Carolina
city: Charlotte
country: United States
facility: Southern Oncology Specialists
state: North Carolina
city: Huntersville
country: United States
facility: Lake Norman Hematology Oncology Specialists
state: North Carolina
city: Huntersville
country: United States
facility: Novant Health Huntersville Medical Center
state: North Carolina
city: Huntersville
country: United States
facility: Southern Oncology Specialists
state: North Carolina
city: Matthews
country: United States
facility: Novant Health Cancer Specialists
state: North Carolina
city: Matthews
country: United States
facility: Novant Health Matthews Medical Center
state: North Carolina
city: Mooresville
country: United States
facility: Lake Norman Hematology Oncology Specialists
state: North Carolina
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute, LLC
state: Oklahoma
city: Portland
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Tigard
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Erie
country: United States
facility: UPMC Hillman Cancer Center Erie
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of UPMC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center
state: Pennsylvania
city: Dickson
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Franklin
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Gallatin
country: United States
facility: Tennessee Oncology PLLC
state: Tennessee
city: Germantown
country: United States
facility: The West Clinic, P.C. d/b/a West Cancer Center
state: Tennessee
city: Hermitage
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Lebanon
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic, P.C. d/b/a West Cancer Center
state: Tennessee
city: Murfreesboro
country: United States
facility: Tennessee Oncology PLLC
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology PLLC
state: Tennessee
city: Shelbyville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Smyrna
country: United States
facility: Tennessee Oncology PLLC
state: Tennessee
city: Arlington
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Austin
country: United States
facility: Texas Oncology-South Austin
state: Texas
city: Burleson
country: United States
facility: The Center for Cancer and Blood Disorders (Huguley)
state: Texas
city: Cedar Park
country: United States
facility: Texas Oncology - Cedar Park
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center
state: Texas
city: El Paso
country: United States
facility: Texas Oncology-El Paso Cancer Treatment Center Grandview
state: Texas
city: El Paso
country: United States
facility: Texas Oncology-El Paso Cancer Treatment Center Gateway
state: Texas
city: El Paso
country: United States
facility: Texas Oncology - El Paso Cancer Treatment Center Joe Battle
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Fort Worth
country: United States
facility: Investigational Products Center (IPC)
state: Texas
city: Houston
country: United States
facility: Texas Oncology-Memorial City
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: University Of Texas, Md Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
city: Irving
country: United States
facility: US Oncology Investigational Product Center (IPC)
state: Texas
city: Irving
country: United States
facility: US Oncology Investigational Products Center (IPC)
state: Texas
city: Irving
country: United States
facility: US Oncology Investigational Products Center(IPC)
state: Texas
city: Plano
country: United States
facility: Texas Oncology-Plano East
state: Texas
city: Round Rock
country: United States
facility: Texas Oncology-Seton Williamson
state: Texas
city: Waco
country: United States
facility: Texas Oncology - Waco
state: Texas
city: Waco
country: United States
facility: Texas Oncology-Waco
state: Texas
city: Weatherford
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Alexandria
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Newport News
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Virginia Beach
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists, P.C.(Admin Only)
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Washington
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Milton
country: Australia
facility: ICON Cancer Care (Haematology And Oncology Clinics Of Australasia (Hoca))-Milton
state: Queensland
city: South Brisbane
country: Australia
facility: Icon Cancer Care, Corporate Office
state: Queensland
city: South Brisbane
country: Australia
facility: ICON Cancer Care
state: Queensland
city: South Brisbane
country: Australia
facility: ICON Cancer Foundation
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Adult Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Icon Cancer Care South Brisbane
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Kurralta Park
country: Australia
facility: Adelaide Cancer Centre
state: South Australia
city: Kurralta Park
country: Australia
facility: Ashford Cancer Centre Research
state: South Australia
city: Kurralta Park
country: Australia
facility: Cancer Care SA PTY Ltd
state: South Australia
city: Kurralta Park
country: Australia
facility: Cancer Care SA trading as Icon Pharmacy Adelaide
state: South Australia
city: East Melbourne
country: Australia
facility: Victoria Breast and Oncology Care
state: Victoria
city: Frankston
country: Australia
facility: Peninsula & South Eastern Haematology and Oncology Group
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health, University Hospital Geelong
state: Victoria
city: Heidelberg West
country: Australia
facility: Austin Health, Heidelberg Repatriation Hospital (radiology (MUGA)scans only)
state: Victoria
city: Melbourne
country: Australia
facility: Austin Health, The Austin Hospital
state: Victoria
city: Mount Waverley
country: Australia
facility: Slade Pharmacy Mount Waverley
state: Victoria
city: Wendouree
country: Australia
facility: Nova Pharmacy
state: Victoria
city: Wendouree
country: Australia
facility: Ballarat Oncology & Haematology Services Clinical Trials Unit
state: Victoria
city: Wendouree
country: Australia
facility: Ballarat Oncology & Haematology Services
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital Lung Institute Of Western Australia
state: Western Australia
city: Auchenflower
country: Australia
facility: River City Pharmacy
city: Milton
country: Australia
facility: Icon Cancer Care
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Liege
country: Belgium
facility: CHU Sart Tilman Liege
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional do Cancer Jose de Alencar Gomes da Silva
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Central de Quimioterapia Hospital do Cancer-INCA-HCIII
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Hospital do Cancer III - INCA / Instituto Nacional do Cancer / MS INCA HCIII
state: RJ
city: Passo Fundo
country: Brazil
facility: Hopital da Cidade de Passo Fundo
state: RS
city: Passo Fundo
country: Brazil
facility: Hospital da Cidade de Passo Fundo - HCPF
state: RS
city: Porto Alegre
country: Brazil
facility: Associacao Hospitalar Moinhos de Vento
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
city: Porto Alegre
country: Brazil
facility: Uniao Brasileira de Educacao E Assistencia
state: RS
city: Barretos
country: Brazil
facility: Hospital do Cancer de Barretos - Fundacao Pio XII
state: SP
city: Jau
country: Brazil
facility: Fundacao Hospital Amaral Carvalho
state: SP
city: Piracicaba
country: Brazil
facility: Instituto de Oncologia de Piracicaba S/S Ltda.
state: SP
city: Sao Paulo
country: Brazil
facility: Centro de Referencia da Saude da Mulher - Hospital Perola Byington
state: SP
city: Sao Paulo
country: Brazil
facility: Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamária Ltda.
state: SP
city: Besancon
country: France
facility: CHRU Jean Minjoz
city: LYON cedex 08
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Nantes BP 20215
country: France
facility: Hopital Prive du Confluent
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Hopital Tenon
city: Saint Herblain
country: France
facility: Institut de Cancerologie de l'Ouest - Site Rene Gauducheau
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbourg - Hopital Civil
city: Toulouse
country: France
facility: Institut Universitaire du Cancer Toulouse - Oncopole
city: Tours Cedex 9
country: France
facility: CHU Bretonneau Centre Henry Kaplan
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy
city: Munich
country: Germany
facility: Medizinisches Zentrum fur Hamatologie und Onkologie Munchen MVZ
state: Bavaria
city: Munich
country: Germany
facility: Radiologicum
state: Bavaria
city: Munich
country: Germany
facility: IOZ Muenchen
state: Bavaria
city: Munich
country: Germany
facility: University of Munich (LMU), Grosshadern Hospital
state: Bavaria
city: Munich
country: Germany
facility: Radiologicum
state: Bavaria
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden
state: Saxony
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin-Buch
city: Berlin
country: Germany
facility: Praxisklinik Krebsheilkunde fuer Frauen/Brustzentrum
city: Duesseldorf
country: Germany
facility: University Hospital Duesseldorf
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen
city: Essen
country: Germany
facility: Kliniken Essen-Mitte, Klinik für Senologie / Brustzentrum
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg, Klinik fuer Frauenheilunde
city: Leer
country: Germany
facility: Oncologie Unter Ems
city: Munich
country: Germany
facility: Klinikum rechts der Isar, TUM, Frauenklinik und Poliklinik
city: Rostock
country: Germany
facility: Unifrauenklinik am Klinikum Suedstadt
city: Ulm
country: Germany
facility: Universitaetsfrauenklinik
city: Dublin 4
country: Ireland
facility: St. Vincent's University Hospital
city: Dublin 7
country: Ireland
facility: Mater Misericordiae University Hospital
city: Galway
country: Ireland
facility: University Hospital Galway
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Oncology Institute, Rambam Health Care Campus
city: Petach Tikva
country: Israel
facility: Oncology Institute, Davidoff Center, Rabin Medical Center, Beilinson Campus
city: Tel Aviv
country: Israel
facility: Division of Oncology Tel Aviv Sourasky Medical Center
city: Tel Aviv
country: Israel
facility: Assuta Medical Center
city: Tel Hashomer
country: Israel
facility: The Chaim sheba Medical Center
city: Tel-Aviv
country: Israel
facility: Oncology Institute, Assuta Medical Center
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
city: Avellino
country: Italy
facility: A.O.S.G. Moscati - Contrada Amoretta
state: AV
city: Milano
country: Italy
facility: Ospedale S. Raffaelle di Milano
state: MI
city: Monza
country: Italy
facility: A.S.S.T. Monza
state: Monza AND Brianza
city: Monza
country: Italy
facility: A.S.S.T. Monza, Oncologia Medica, Ospedale San Gerardo
state: Monza Brianza
city: Palermo
country: Italy
facility: La Maddalena Clinic For Cancer University Of Palermo
state: PA
city: Pisa
country: Italy
facility: A.O.U. Pisana, DAI Oncologia, U.O. Oncologia Med. 2 Univ.
state: PI
city: Roma
country: Italy
facility: Ospendale Sant'Andrea
state: RM
city: Legnago
country: Italy
facility: Ospedale Mater Salutis
state: VR
city: Bologna
country: Italy
facility: S.S.D. Oncologia Medica Addarii - A.O.U. di Bologna - Policlinico Sant'Orsola-Malpighi
city: Milano
country: Italy
facility: Senologia Medica, IRCCS-Instituto Oncologico Europeo (IEO)
city: Roma
country: Italy
facility: Universita Campus Bio-Medico di Roma, Dipartimento Oncologia Medica
city: Bundang-gu
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Centre
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna
state: LODZ Province
city: Dobra
country: Poland
facility: NZOZ Innowacyjna Medycyna
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne, Zaklad Medycyny Nuklearnej
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne, Zaklad Radiologii
city: Gliwice
country: Poland
facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Oddzial w Gliwicach
city: Katowice
country: Poland
facility: NU-MED Centrum Diagnostyki i Terapii Onkologicznej Katowice
city: Katowice
country: Poland
facility: Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu
city: Otwock
country: Poland
facility: Europejskie Centrum Zdrowia Otwock Szpital im.F.Chopina
city: Poznan
country: Poland
facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
city: Poznan
country: Poland
facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Pozna
city: Poznan
country: Poland
facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola
city: Poznan
country: Poland
facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Pozna
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
city: Szczecin
country: Poland
facility: Oddzial Onkologii Klinicznej, Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie
city: Szczecin
country: Poland
facility: Pracownia Tomografii Komputerowej , Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie
city: Szczecin
country: Poland
facility: Pracownia Medycyny Nuklearnej, 109 Szpital Wojskowy z Przychodnia SP ZOZ
city: Warszawa
country: Poland
facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Nowotworow Piersi i
city: Warszawa
country: Poland
facility: Klinika Onkologii, Wojskowy lnstytut Medyczny
city: Leningrad
country: Russian Federation
facility: Gbuz Lood
state: Leningrad Region
city: Petrozavodsk
country: Russian Federation
facility: State Budgetary Institution of Healthcare "Republican Oncology dispensary"'
city: St. Petersburg
country: Russian Federation
facility: City Clinical Oncology Dispensary
city: Avila
country: Spain
facility: Hospital Nuestra Senora de Sonsoles(Complejo Asistencial de Avila)
city: Badalona Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial
city: Castellon
country: Spain
facility: Consorcio Hospitalario Provincial de Castellon
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen
city: La Coruna
country: Spain
facility: Centro Oncologico de Galicia
city: La Laguna Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova de Lleida
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Pozuelo De Alarcon (Madrid)
country: Spain
facility: Hospital Universitario Quiron Madrid
city: Sabadell Barcelona
country: Spain
facility: Corporacio Sanitaria Parc Tauli
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center
city: Kriviy Rig
country: Ukraine
facility: Communal Institution "Krivorizhskiy Oncology Dispensary" of Dnipropetrovsk Regional Council
city: Sumy
country: Ukraine
facility: Regional Municipal Institution "Sumy Regional Clinical Oncology Dispensary", Thoracic Department
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK
state: England
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital NHS Trust
state: Nottinghamshire
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital, Royal Alexandra Children's Hospital L10
city: Leeds
country: United Kingdom
facility: St James University Hospital
city: London
country: United Kingdom
facility: Impretial College Healthcare NHS Trust
city: Manchester
country: United Kingdom
facility: Cancer Research UK, Department of Medical Oncology - The Christie NHS Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Ettl 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.
citation: Litton 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.