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

Breast Neoplasms Clinical Trial

— EMBRACA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01945775
• Other study ID #: 673-301
• Secondary ID: C34410092013-002
• Status: Completed
• Phase: Phase 3
• Start date: October 14, 2013
• Est. completion date: March 5, 2021

Study information

• Verified date: December 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 431
• Est. completion date: March 5, 2021
• Est. primary completion date: September 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• BRCA 1 Gene Mutation
• BRCA 2 Gene Mutation
• Breast Neoplasms

Intervention

Drug:
• talazoparib
Until progression or unacceptable toxicity develops
• Physician's-Choice
Capecitabine, Eribulin, Gemcitabine or Vinorelbine

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Medivation, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  France,  Germany,  Ireland,  Israel,  Italy,  Korea, Republic of,  Poland,  Russian Federation,  Spain,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of Response (DOR): Investigator Assessment	DOR = time from first radiographic documentation of OR (PR or CR) till radiographic disease progression (PD) as per RECIST v1.1 by investigator assessment or to death due to any cause, whichever was first. RECIST 1.1, a) target lesion (TL): CR= disappearance of all non-nodal TL, target lymph nodes reduce to <10 mm in short axis, PR= at least 30% decrease in sum of diameters of TL, compared to the sum at baseline, PD= at least 20% increase in sum of TL measurements, compared to smallest sum on study including baseline, absolute increase in sum has to be at least 5 mm; b) for non-TL: CR= disappearance of all non-TL, PD= unequivocal progression of non-TL, such that treatment has failed, disease is progressing, regardless of status of TL; c) PD =and/or appearance of >=1 new lesions. DOR = (earliest date of progression, death, or censoring-date of first documented OR + 1)/30.4375. Analysis was performed by Kaplan-Meier method.	From first documentation of CR or PR until disease progression or death due to any cause, whichever occurred first (up to 36.9 months)
Other	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	EORTC QLQ-C30: cancer-specific instrument with 30 questions to assess the participant QoL. First 28 questions used to evaluate 5 functional scales (physical, role, cognitive, emotional, social), 3 symptom scales (fatigue, nausea and vomiting, pain) and other single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Each question assessed on 4-point scale (1= not at all, 2= a little, 3= quite a bit, 4= very much); functional scales: higher score = better level of functioning; symptom scale: higher score = more severe symptoms; for single items: higher score= more severe problem. Last 2 questions used to evaluate global health status (GHS)/QoL. Each question was assessed on 7-point scale (1= very poor to 7= excellent). Scores averaged, transformed to 0-100 scale; higher score=better quality of life/better level of functioning. Change from baseline was calculated by subtracting the baseline value from the average value of Week 4 to 160.	Baseline, Week 4 up to Week 160
Other	Time to Deterioration (TTD) in Global Health Status/Quality of Life (QOL)	TTD in global health status (GHS)/QoL=time (in months) from randomization to the first observation with >=10 point decrease and no subsequent observations with<10 point decrease from baseline in GHS/QoL score based on EORTC-QLQ-C30. EORTC QLQ-C30 is a cancer-specific instrument with 30 questions to assess participant quality of life. Question 29 and 30 were used to evaluate GHS/QoL. Each question was assessed on a 7-point scale (1=very poor to 7=excellent). Scores averaged, transformed to 0-100 scale; higher score=better quality of life/better level of functioning.	Baseline up to a maximum duration of 36.9 months
Other	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)	TTD was defined as the time (in months) from randomization to the first observation with a>=10 point increase and no subsequent observations with a <10 point increase from baseline in breast symptom score based on the EORTC-QLQ-BR23. EORTC-QLQ-BR23 is a disease-specific module for breast cancer developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer. EORTC-QLQ-BR23 symptoms subscale includes 4 items: systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss. Each item is rated by choosing 1 of 4 possible responses that record the level of intensity (1= not at all, 2= a little, 3= quite a bit, and 4= very much), higher scores=high level of symptom/problems.	Baseline up to a maximum duration of 36.9 months
Primary	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	Percentage of Participants With Objective Response: Investigator Assessment	Investigator assessed objective response was defined as the percentage of participants with a partial response (PR) or complete response (CR) as defined by RECIST v1.1. For target lesions: 1) CR: disappearance of all non-nodal target lesions. Target lymph nodes must reduce to less than 10 mm in short axis. 2) PR: At least a 30% decrease in the sum of diameters of target lesions, compared to the sum at baseline. For non-target lesions, CR: disappearance of all non-target lesions. Percentage of participants with objective response reported are based upon unconfirmed CR/PR.	Baseline until radiologic progressive disease or death due to any cause (up to a maximum duration of 36.9 months)
Secondary	Overall Survival (OS)	OS was defined as the time (in months) from randomization to death due to any cause. If death was not observed at the time of study cut-off date or permanently lost to follow-up, OS was censored at the date the participant was last known to be alive on or before the study cut-off date, whichever was earlier. The analysis was performed by Kaplan-Meier method.	Baseline until death due to any cause or analysis cut-off, up to a maximum duration of 61.4 months
Secondary	Trough Plasma Talazoparib Concentrations	A predose PK sample was considered dose-compliant based on the following criteria: A participant must have received 21 consecutive days of 1 mg talazoparib without dosing interruption prior to sample collection; and the predose PK sample must have been collected 24 hours +/- 10 percent (2 hours and 24 minutes) after the previous day's dose and no more than 5 minutes (0.083 hours) after the administration of the dose on the day of PK sample collection.	Predose on Day 1 of Cycle 2, 3 and 4
Secondary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	An adverse events (AE) was any untoward medical occurrence (e.g., sign, symptom, illness, disease or injury) in a participant administered study drug or other protocol-imposed intervention, regardless of attribution. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug or the day before initiation of a new antineoplastic therapy or 30 days after the date of the last dose date of study drug, whichever occurred first, that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and all non-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
Secondary	Number of Participants With Grade 3 or 4 Post-baseline Toxicities in Laboratory Parameters: Hematology	Toxicity grades were evaluated based on as National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03). NCI CTCAE v4.03 defined the severity grade as: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (potentially life threatening) and grade 5 (death related to AE) for each parameter. Key hematology parameters included hemoglobin (gram per liter [g/L]), leukocytes (10^6 cells per liter), lymphocytes (10^6 cells per liter), neutrophils (10^6 cells per liter), and platelets (10^9 cells per liter). Low value indicated lower values than the baseline values and high value indicated higher values than the baseline values. Only those categories in which at least 1 participant had data were reported.	Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months.
Secondary	Number of Participants With Grade 3 or 4 Post-baseline Toxicities in Laboratory Parameters: Chemistry	Toxicity grades were evaluated based on as NCI CTCAE v4.03. NCI CTCAE v4.03 defined the severity grade as: grade 1 (mild), grade 2 (moderate), grade 3 (severe) and grade 4 (potentially life threatening) and grade 5 (death related to AE) for each parameter. Key chemistry parameters included alanine aminotransferase (units per liter), alkaline phosphatase (units per liter), aspartate aminotransferase (units per liter) and bilirubin (micromole per liter). High value indicated higher values than the baseline values and low value indicated lower values than the baseline values. Only those categories in which at least 1 participant had data were reported.	Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months
Secondary	Number of Participants With Potentially Clinically Significant Changes From Baseline in Vital Signs	Criteria for potentially clinically significant changes in vital signs included a) Systolic blood pressure: 1) absolute results (AB) greater than (>) 180 millimeter of mercury (mmHg) and increase from baseline (IFB) greater than or equal to (>=) 40 mmHg, 2) absolute results less than (<) 90 mmHg and decrease from baseline (DFB) >30 mmHg; b) Diastolic blood pressure: 1) absolute results >110 mmHg and >=30 mmHg increase from baseline, 2) absolute results <50 mmHg and >20 mmHg decrease from baseline 3) >=20 mmHg increase from baseline; c) Heart rate: 1) absolute results>120 beats per minute [bpm] and >30 bpm increase from baseline, 2) absolute results <50 bpm and >20 bpm decrease from baseline and d) Weight: >10 percent [%] decrease from baseline.	Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months
Secondary	Number of Participants Taking At-least One Concomitant Medication	Any medication (other than study drug) which was administered to participants during study after first dose of study drug were considered as concomitant medications.	Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months