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

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms; BRCA 1 Gene Mutation; BRCA 2 Gene Mutation
• Intervention / Treatment: Drug: talazoparib; Drug: Physician's-Choice

• Study Type: Interventional
• Enrollment (Actual): 431
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Auchenflower, Australia, 4066
    • River City Pharmacy
  • Milton, Australia, 4066
    • ICON Cancer Care
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital
  • Queensland
    • Milton, Queensland, Australia, 4064
      • ICON Cancer Care (Haematology And Oncology Clinics Of Australasia (Hoca))-Milton
    • South Brisbane, Queensland, Australia, 4101
      • ICON Cancer Care
    • South Brisbane, Queensland, Australia, 4101
      • Mater Adult Hospital
    • South Brisbane, Queensland, Australia, 4101
      • Icon Cancer Foundation
    • South Brisbane, Queensland, Australia, 4101
      • Icon Cancer Care, Corporate Office
    • South Brisbane, Queensland, Australia, 4104
      • Icon Cancer Care South Brisbane
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Medical Centre
    • Kurralta Park, South Australia, Australia, 5037
      • Ashford Cancer Centre Research
    • Kurralta Park, South Australia, Australia, 5037
      • Adelaide Cancer Centre
    • Kurralta Park, South Australia, Australia, 5037
      • Cancer Care SA Pty Ltd
    • Kurralta Park, South Australia, Australia, 5037
      • Cancer Care SA trading as Icon Pharmacy Adelaide
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Victoria Breast and Oncology Care
    • Frankston, Victoria, Australia, 3199
      • Peninsula & South Eastern Haematology and Oncology Group
    • Geelong, Victoria, Australia, 3220
      • Barwon Health, University Hospital Geelong
    • Heidelberg West, Victoria, Australia, 3081
      • Austin Health, Heidelberg Repatriation Hospital (radiology (MUGA)scans only)
    • Melbourne, Victoria, Australia, 3084
      • Austin Health, The Austin Hospital
    • Mount Waverley, Victoria, Australia, 3149
      • Slade Pharmacy Mount Waverley
    • Wendouree, Victoria, Australia, 3355
      • Ballarat Oncology & Haematology Services
    • Wendouree, Victoria, Australia, 3353
      • Nova Pharmacy
    • Wendouree, Victoria, Australia, 3355
      • Ballarat Oncology & Haematology Services Clinical Trials Unit
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
    • Nedlands, Western Australia, Australia, 6009
      • Sir Charles Gairdner Hospital Lung Institute Of Western Australia
• Belgium
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Liege, Belgium, B-4000
    • CHU Sart Tilman Liege
• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil, 20230-130
      • Instituto Nacional do Cancer Jose de Alencar Gomes da Silva
    • Rio de Janeiro, RJ, Brazil, 20560-120
      • Central de Quimioterapia Hospital do Cancer-INCA-HCIII
    • Rio de Janeiro, RJ, Brazil, 20560-120
      • Hospital do Cancer III - INCA / Instituto Nacional do Cancer / MS INCA HCIII
  • RS
    • Passo Fundo, RS, Brazil, 99010-260
      • Hopital da Cidade de Passo Fundo
    • Passo Fundo, RS, Brazil, 99010-260
      • Hospital da Cidade de Passo Fundo - HCPF
    • Porto Alegre, RS, Brazil, 90035-903
      • Hospital de Clinicas de Porto Alegre
    • Porto Alegre, RS, Brazil, 90035-001
      • Associacao Hospitalar Moinhos de Vento
    • Porto Alegre, RS, Brazil, 90610-000
      • União Brasileira de Educação e Assistência
  • SP
    • Barretos, SP, Brazil, 14784-400
      • Hospital do Cancer de Barretos - Fundacao Pio XII
    • Jau, SP, Brazil, 17210-120
      • Fundacao Hospital Amaral Carvalho
    • Piracicaba, SP, Brazil, 13419-155
      • Instituto de Oncologia de Piracicaba S/S Ltda.
    • Sao Paulo, SP, Brazil, 01317-000
      • Centro de Referencia da Saude da Mulher - Hospital Perola Byington
    • Sao Paulo, SP, Brazil, 01317-001
      • Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamária Ltda.
• France
  • Besancon, France, 25030
    • CHRU Jean Minjoz
  • LYON cedex 08, France, 69373
    • Centre Leon Berard
  • Marseille, France, 13273 Cedex 9
    • Institut Paoli Calmettes
  • Nantes BP 20215, France, 44202 Cedex 2
    • Hopital Prive du Confluent
  • Paris, France, 75010
    • Hopital Saint Louis
  • Paris, France, 75020
    • Hopital Tenon
  • Saint Herblain, France, 44805 Cedex
    • Institut de Cancérologie de l'Ouest - Site René Gauducheau
  • Strasbourg, France, 67200
    • Hôpitaux Universitaires de Strasbourg - Hôpital Civil
  • Toulouse, France, 31059 Cedex 9
    • Institut Universitaire Du Cancer Toulouse - Oncopole
  • Tours Cedex 9, France, 37044
    • CHU Bretonneau Centre Henry Kaplan
  • Villejuif Cedex, France, 94805
    • Institut Gustave Roussy
• Germany
  • Berlin, Germany, 13125
    • Helios Klinikum Berlin-Buch
  • Berlin, Germany, 13595
    • Praxisklinik Krebsheilkunde fuer Frauen/Brustzentrum
  • Duesseldorf, Germany, 40225
    • University Hospital Duesseldorf
  • Erlangen, Germany, 91054
    • Universitaetsklinikum Erlangen
  • Essen, Germany, 45136
    • Kliniken Essen-Mitte, Klinik für Senologie / Brustzentrum
  • Freiburg, Germany, 79106
    • Universitaetsklinikum Freiburg, Klinik fuer Frauenheilunde
  • Leer, Germany, 26789
    • Oncologie Unter Ems
  • Munich, Germany, 81675
    • Klinikum rechts der Isar, TUM, Frauenklinik und Poliklinik
  • Rostock, Germany, 18059
    • Unifrauenklinik am Klinikum Suedstadt
  • Ulm, Germany, 89075
    • Universitaetsfrauenklinik
  • Bavaria
    • Munich, Bavaria, Germany, 80639
      • Medizinisches Zentrum fur Hamatologie und Onkologie Munchen MVZ
    • Munich, Bavaria, Germany, 81331
      • Radiologicum
    • Munich, Bavaria, Germany, 81377
      • IOZ Muenchen
    • Munich, Bavaria, Germany, 81377
      • University of Munich (LMU), Grosshadern Hospital
    • Munich, Bavaria, Germany, 81539
      • Radiologicum
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden
• Ireland
  • Dublin 4, Ireland
    • St. Vincent's University Hospital
  • Dublin 7, Ireland
    • Mater Misericordiae University Hospital
  • Galway, Ireland
    • University Hospital Galway
• Israel
  • Beer Sheva, Israel, 84101
    • Soroka University Medical Center
  • Haifa, Israel, 31096
    • Oncology Institute, Rambam Health Care Campus
  • Petach Tikva, Israel, 49100
    • Oncology Institute, Davidoff Center, Rabin Medical Center, Beilinson Campus
  • Tel Aviv, Israel, 69710
    • Assuta Medical Center
  • Tel Aviv, Israel, 64239
    • Division of Oncology Tel Aviv Sourasky Medical Center
  • Tel Hashomer, Israel, 5265601
    • The Chaim Sheba Medical Center
  • Tel-Aviv, Israel, 69710
    • Oncology Institute, Assuta Medical Center
  • Zerifin, Israel, 70300
    • Assaf Harofeh Medical Center
• Italy
  • Bologna, Italy, 1-40138
    • S.S.D. Oncologia Medica Addarii - A.O.U. di Bologna - Policlinico Sant'Orsola-Malpighi
  • Milano, Italy, I-20141
    • Senologia Medica, IRCCS-Instituto Oncologico Europeo (IEO)
  • Roma, Italy, I-00128
    • Universita Campus Bio-Medico di Roma, Dipartimento Oncologia Medica
  • AV
    • Avellino, AV, Italy, 83100
      • A.O.S.G. Moscati - Contrada Amoretta
  • MI
    • Milano, MI, Italy, 20132
      • Ospedale S. Raffaelle di Milano
  • Monza AND Brianza
    • Monza, Monza AND Brianza, Italy, I-20900
      • A.S.S.T. Monza
  • Monza Brianza
    • Monza, Monza Brianza, Italy, I-20900
      • A.S.S.T. Monza, Oncologia Medica, Ospedale San Gerardo
  • PA
    • Palermo, PA, Italy, 90146
      • La Maddalena Clinic For Cancer University Of Palermo
  • PI
    • Pisa, PI, Italy, I-56126
      • A.O.U. Pisana, DAI Oncologia, U.O. Oncologia Med. 2 Univ.
  • RM
    • Roma, RM, Italy, 00189
      • Ospendale Sant'Andrea
  • VR
    • Legnago, VR, Italy, 37045
      • Ospedale Mater Salutis
• Korea, Republic of
  • Daegu, Korea, Republic of, 41404
    • Kyungpook National University Chilgok Hospital
  • Incheon, Korea, Republic of, 21565
    • Gachon University Gil Medical Center
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea, Seoul ST. Mary's Hospital
  • Seoul, Korea, Republic of, 07985
    • Ewha Womans University Mokdong Hospital
  • Ulsan, Korea, Republic of, 44033
    • Ulsan University Hospital
  • Gyeonggi-do
    • Bundang-gu, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
      • National Cancer Centre
    • Suwon, Gyeonggi-do, Korea, Republic of, 16499
      • Ajou University Hospital
• Poland
  • Dobra, Poland, 72-003
    • NZOZ Innowacyjna Medycyna
  • Gdansk, Poland, 80-952
    • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
  • Gdansk, Poland, 80-952
    • Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii
  • Gdansk, Poland, 80-211
    • Uniwersyteckie Centrum Kliniczne, Zaklad Medycyny Nuklearnej
  • Gdansk, Poland, 80-952
    • Uniwersyteckie Centrum Kliniczne, Zaklad Radiologii
  • Gliwice, Poland, 44-101
    • Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Oddzial w Gliwicach
  • Katowice, Poland, 40-514
    • NU-MED Centrum Diagnostyki i Terapii Onkologicznej Katowice
  • Katowice, Poland, 40-514
    • Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu
  • Otwock, Poland, 05-400
    • Europejskie Centrum Zdrowia Otwock Szpital im.F.Chopina
  • Poznan, Poland, 60-355
    • Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
  • Poznan, Poland, 60-569
    • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Pozna
  • Poznan, Poland, 60-569
    • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola
  • Poznan, Poland, 61-848
    • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Pozna
  • Poznan, Poland, 61-866
    • Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
  • Szczecin, Poland, 70-111
    • Oddzial Onkologii Klinicznej, Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie
  • Szczecin, Poland, 70-111
    • Pracownia Tomografii Komputerowej , Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie
  • Szczecin, Poland, 70-965
    • Pracownia Medycyny Nuklearnej, 109 Szpital Wojskowy z Przychodnia SP ZOZ
  • Warszawa, Poland, 02-781
    • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Nowotworow Piersi i
  • Warszawa, Poland, 04-141
    • Klinika Onkologii, Wojskowy lnstytut Medyczny
  • LODZ Province
    • Lodz, LODZ Province, Poland, 90-242
      • Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna
• Russian Federation
  • Petrozavodsk, Russian Federation, 185002/185007
    • State Budgetary Institution of Healthcare "Republican Oncology dispensary"'
  • St. Petersburg, Russian Federation, 197022
    • City Clinical Oncology Dispensary
  • Leningrad Region
    • Leningrad, Leningrad Region, Russian Federation, 188663
      • Gbuz Lood
• Spain
  • Avila, Spain, 05004
    • Hospital Nuestra Senora de Sonsoles(Complejo Asistencial de Avila)
  • Badalona Barcelona, Spain, 08916
    • Hospital Universitari Germans Trias i Pujol
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08036
    • Hospital Clinic I Provincial
  • Castellon, Spain, 12002
    • Consorcio Hospitalario Provincial de Castellon
  • Jaen, Spain, 23007
    • Complejo Hospitalario de Jaen
  • La Coruna, Spain, 15009
    • Centro Oncologico de Galicia
  • La Laguna Santa Cruz De Tenerife, Spain, 38320
    • Hospital Universitario de Canarias
  • Lleida, Spain, 25198
    • Hospital Universitari Arnau de Vilanova de Lleida
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28006
    • Hospital Universitario de La Princesa
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon
  • Pozuelo De Alarcon (Madrid), Spain, 28223
    • Hospital Universitario Quiron Madrid
  • Sabadell Barcelona, Spain, 08208
    • Corporacio Sanitaria Parc Tauli
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
• Taiwan
  • Changhua, Taiwan, 500
    • Changhua Christian Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 112
    • Koo Foundation Sun Yat-Sen Cancer Center
• Ukraine
  • Kriviy Rig, Ukraine, 50048
    • Communal Institution "Krivorizhskiy Oncology Dispensary" of Dnipropetrovsk Regional Council
  • Sumy, Ukraine, 40005
    • Regional Municipal Institution "Sumy Regional Clinical Oncology Dispensary", Thoracic Department
• United Kingdom
  • Brighton, United Kingdom, BN2 2BE
    • Royal Sussex County Hospital, Royal Alexandra Children's Hospital L10
  • Leeds, United Kingdom, LS9 7TF
    • St James University Hospital
  • London, United Kingdom, W6 8RF
    • Impretial College Healthcare NHS Trust
  • Manchester, United Kingdom, M20 4BX
    • Cancer Research UK, Department of Medical Oncology - The Christie NHS Foundation Trust
  • England
    • London, England, United Kingdom, W1G 6AD
      • Sarah Cannon Research Institute UK
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • Nottingham University Hospital NHS Trust
• United States
  • Arizona
    • Flagstaff, Arizona, United States, 86001
      • Arizona Oncology Associates P.C. - NAHOA
    • Scottsdale, Arizona, United States, 85258
      • HonorHealth
    • Scottsdale, Arizona, United States, 85258
      • Virginia G. Piper Cancer Pharmacy
  • California
    • Antioch, California, United States, 94509
      • Kaiser Permanente Medical Center Lab Drawing Station
    • Antioch, California, United States, 94531
      • Kaiser Permanente Medical Center Lab Drawing Station
    • Bakersfield, California, United States, 93309
      • CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
    • Fairfield, California, United States, 94533-6901
      • Kaiser Permanente Medical Center Lab Drawing Station
    • Fullerton, California, United States, 92835
      • St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare
    • Gilroy, California, United States, 95020
      • Kaiser Permanente Medical Center Lab Drawing Station
    • Glendale, California, United States, 91204
      • Los Angeles Hematology Oncology Medical Group
    • Glendale, California, United States, 91206
      • Los Angeles Hematology Oncology Medical Group
    • Greenbrae, California, United States, 94904
      • Marin Specialty Care
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles
    • Los Angeles, California, United States, 90095
      • Ronald Reagan UCLA Medical Center
    • Los Angeles, California, United States, 90095-7349
      • UCLA West Medical Pharmacy, Attn: Steven L. Wong
    • Los Angeles, California, United States, 90095
      • TRIO-US Central Administration
    • Los Angeles, California, United States, 90057
      • Los Angeles Hematology Oncology Medical Group
    • Los Angeles, California, United States, 90017
      • Los Angeles Hematology Oncolgy Medical Group
    • Los Angeles, California, United States, 90095-7349
      • Drug Management Only: UCLA West Medical Pharmacy, Attn:Steven L. Wong, Pharm.D.
    • Los Angeles, California, United States, 90095-7349
      • Drug Management Only: UCLA West Medical Pharmacy
    • Los Angeles, California, United States, 90095-7349
      • UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm. D.
    • Los Angeles, California, United States, 90095-7349
      • UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.
    • Los Angeles, California, United States, 90095-7349
      • UCLA West Medical Pharmacy, Attn:Steven L. Wong, Pharm.D.
    • Los Angeles, California, United States, 90095
      • Regulatory Managment Only: TRIO-US Central Administration
    • Los Angeles, California, United States, 90095
      • UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.
    • Martinez, California, United States, 94553
      • Kaiser Permanente Medical Center Lab Drawing Station
    • Milpitas, California, United States, 95035-5491
      • Kaiser Permanente Medical Center Lab Drawing Station
    • Modesto, California, United States, 95356
      • Kaiser Permanente Medical Center Lab Drawing Station
    • Mountain View, California, United States, 94041
      • Kaiser Permanente Medical Center Lab Drawing Station
    • Napa, California, United States, 94558-3313
      • Kaiser Permanente Medical Center Lab Drawing Station
    • Oakland, California, United States, 94611
      • Kaiser Permanente Medical Center (clinic+DSL)
    • Oakland, California, United States, 94611
      • Kaiser Permanente Medical Center (Radiology)
    • Pleasanton, California, United States, 94558
      • Kaiser Permanente Medical Center Lab Drawing Station
    • Redondo Beach, California, United States, 90277
      • Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates
    • Redwood City, California, United States, 94063
      • Kaiser Permanente Medical Center Lab Drawing Station
    • Roseville, California, United States, 95661
      • Kaiser Permanente Medical Center (clinic+DSL)
    • San Diego, California, United States, 92120
      • Southern California Permanente Medical Group
    • San Francisco, California, United States, 94115
      • UCSF - Helen Diller Family Comprehensive Cancer Center
    • San Francisco, California, United States, 94158
      • UCSF Helen Diller Comprehensive Cancer Centre - Precision Cancer Medicine Building
    • San Francisco, California, United States, 94518
      • Kaiser Permanente Mission Bay Medical Center Lab Drawing Station
    • San Jose, California, United States, 95110
      • Kaiser Permanente Medical Center Lab Drawing Station
    • San Leandro, California, United States, 94577
      • Kaiser Permanente Medical Center (clinic+DSL)
    • San Luis Obispo, California, United States, 93401
      • Pacific Central Coast Health Centers - San Luis Obispo Oncology and Hematology Health Center
    • Santa Barbara, California, United States, 93105
      • Santa Barbara Cottage Hospital
    • Santa Barbara, California, United States, 93105
      • Ridley Tree Cancer Center
    • Santa Clara, California, United States, 95051
      • Kaiser Permanente Medical Center (clinic+DSL)
    • Santa Maria, California, United States, 93454
      • Central Coast Medical Oncology Corporation
    • Santa Monica, California, United States, 90404
      • UCLA Hematology/Oncology - Parkside
    • Santa Monica, California, United States, 90404
      • UCLA Hematology Oncology
    • Santa Monica, California, United States, 90404
      • UCLA Santa Monica Medical Center & Orthopaedic Hospital
    • Santa Rosa, California, United States, 95403
      • Sutter Pacific Medical Foundation
    • Santa Rosa, California, United States, 95403
      • Sutter North Bay Health Plaza
    • Santa Rosa, California, United States, 95403
      • Sutter Santa Rosa Regional Hospital
    • Solvang, California, United States, 93463
      • Ridley Tree Cancer Center
    • South San Francisco, California, United States, 94080
      • Kaiser Permanente Medical Center (clinic+DSL)
    • Stanford, California, United States, 94305
      • Stanford Cancer Institute
    • Stanford, California, United States, 94305
      • Stanford Women's Cancer Center
    • Valencia, California, United States, 91355
      • UCLA Hematology/Oncology - Santa Clarita
    • Vallejo, California, United States, 94589
      • Kaiser Permanente Medical Center (clinic+DSL)
    • Walnut Creek, California, United States, 94596
      • Kaiser Permanente Medical Center (clinic+DSL)
    • Woodland Hills, California, United States, 91367
      • Southern California Permanente Medical Group
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Rocky Mountain Cancer Centers
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center - Anschutz Cancer Pavilion (ACP)
    • Boulder, Colorado, United States, 80303
      • Rocky Mountain Cancer Centers
    • Colorado Springs, Colorado, United States, 80907
      • Rocky Mountain Cancer Centers
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Centers
    • Denver, Colorado, United States, 80220
      • Rocky Mountain Cancer Centers
    • Lakewood, Colorado, United States, 80228
      • Rocky Mountain Cancer Centers
    • Littleton, Colorado, United States, 80120-4413
      • Rocky Mountain Cancer Centers
    • Lone Tree, Colorado, United States, 80124
      • Rocky Mountain Cancer Centers
    • Longmont, Colorado, United States, 80501
      • Rocky Mountain Cancer Centers
    • Parker, Colorado, United States, 80138
      • Rocky Mountain Cancer Centers
    • Pueblo, Colorado, United States, 81008
      • Rocky Mountain Cancer Centers
    • Thornton, Colorado, United States, 80260
      • Rocky Mountain Cancer Centers
  • Connecticut
    • Plainville, Connecticut, United States, 06062
      • Cancer Center of Central Connecticut
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Florida Cancer Specialists
    • Brandon, Florida, United States, 33511
      • Florida Cancer Specialists
    • Clearwater, Florida, United States, 33761
      • Florida Cancer Specialists
    • Deerfield Beach, Florida, United States, 33442
      • Sylvester Comprehensive Cancer Center Deerfield Beach
    • Gainesville, Florida, United States, 32605
      • Florida Cancer Specialists
    • Hollywood, Florida, United States, 33021
      • Memorial Regional Hospital
    • Hollywood, Florida, United States, 33021
      • Memorial Healthcare System
    • Hudson, Florida, United States, 34667
      • Florida Cancer Specialists
    • Jacksonville, Florida, United States, 32256
      • Cancer Specialists of North Florida
    • Jacksonville, Florida, United States, 32204
      • Cancer Specialists of North Florida
    • Jacksonville, Florida, United States, 32003
      • Cancer Specialists of North Florida
    • Jacksonville, Florida, United States, 32207
      • Cancer Specialists of North Florida
    • Jacksonville, Florida, United States, 32258
      • Cancer Specialists of North Florida
    • Jacksonville Beach, Florida, United States, 32250
      • Cancer Specialists of North Florida
    • Lady Lake, Florida, United States, 32159
      • Florida Cancer Specialists
    • Largo, Florida, United States, 33770
      • Florida Cancer Specialists
    • Lecanto, Florida, United States, 34461
      • Florida Cancer Specialists
    • Miami, Florida, United States, 33136
      • "University of Miami Hospital & Clinics,Sylvester Comprehensive Cancer Center/UMHC"
    • Miami, Florida, United States, 33176
      • Sylvester Comprehensive Cancer Center Kendall
    • New Port Richey, Florida, United States, 34655
      • Florida Cancer Specialists
    • Orange City, Florida, United States, 32763
      • Florida Cancer Specialists
    • Orlando, Florida, United States, 32806
      • Florida Cancer Specialists
    • Orlando, Florida, United States, 32806
      • Orlando Health, Inc
    • Plantation, Florida, United States, 33324
      • Sylvester Comprehensive Cancer Center Plantation
    • Saint Augustine, Florida, United States, 32086
      • Cancer Specialists of North Florida
    • Saint Petersburg, Florida, United States, 33705
      • Florida Cancer Specialists
    • Spring Hill, Florida, United States, 34608
      • Florida Cancer Specialists
    • Tampa, Florida, United States, 33607
      • Florida Cancer Specialists
    • Tavares, Florida, United States, 32778
      • Florida Cancer Specialists
  • Georgia
    • Macon, Georgia, United States, 31201
      • Central Georgia Cancer Care, PC
    • Warner Robins, Georgia, United States, 31088-2259
      • Central Georgia Cancer Care, PC
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Sidney and Lois Eskenazi Hospital
    • Indianapolis, Indiana, United States, 46202
      • IU Health University Hospital
    • Indianapolis, Indiana, United States, 46290
      • Springmill Medical Clinic
    • Indianapolis, Indiana, United States, 46202
      • Indiana University- Melvin and Bren Simon Cancer Center (IUSCC)
  • Kansas
    • Fairway, Kansas, United States, 66205
      • The University of Kansas Cancer Center (Regulatory Office)
    • Kansas City, Kansas, United States, 66112
      • The University of Kansas Cancer Center
    • Overland Park, Kansas, United States, 66210
      • The University of Kansas Cancer Center
    • Westwood, Kansas, United States, 66205
      • The University of Kansas Cancer Center - Investigational Drug Services
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland, Greenebaum Comprehensive Cancer Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System
    • Grand Rapids, Michigan, United States, 49506
      • Cancer and Hematology Centers of Western Michigan
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Minnesota Oncology Hematology, P.A.
    • Edina, Minnesota, United States, 55435-2150
      • Minnesota Oncology Hematology, P.A.
    • Fridley, Minnesota, United States, 55432
      • Minnesota Oncology Hematology, P.A.
    • Maplewood, Minnesota, United States, 55109
      • Minnesota Oncology Hematology, P.A.
    • Minneapolis, Minnesota, United States, 55404
      • Minnesota Oncology Hematology, P.A.
    • Saint Paul, Minnesota, United States, 55102-2389
      • Minnesota Oncology Hematology, P.A.
    • Woodbury, Minnesota, United States, 55125
      • Minnesota Oncology Hematology, P.A.
  • Mississippi
    • Corinth, Mississippi, United States, 38834
      • The West Clinic, P.C.
    • Southaven, Mississippi, United States, 38671
      • The West Clinic, P.C. d/b/a West Cancer Center
  • Missouri
    • Kansas City, Missouri, United States, 64131
      • The University of Kansas Cancer Center
    • Kansas City, Missouri, United States, 64154
      • The University of Kansas Cancer Center
    • Lee's Summit, Missouri, United States, 64064
      • The University of Kansas Cancer Center
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Comprehensive Cancer Centers of Nevada
  • New York
    • Albany, New York, United States, 12208
      • New York Oncology Hematology, P.C.
    • Bronx, New York, United States, 10469
      • Eastchester Center for Cancer Care
    • Clifton Park, New York, United States, 12065
      • New York Oncology Hematology, P.C.
    • New York, New York, United States, 10065
      • Weill Cornell Medical Center
    • New York, New York, United States, 10016
      • New York University Langone Medical Center
    • New York, New York, United States, 10021
      • Weill Cornell Medical College - New York Presbyterian Hospital
    • New York, New York, United States, 10021
      • Weill Cornell Medical College - New York-Presbyterian Hospital
    • New York, New York, United States, 10065
      • Weill Cornell Medical College - New York Presbyterian Hospital
    • New York, New York, United States, 10065
      • New York-Presbyterian Hospital/Weill Cornell Medical Center
    • New York, New York, United States, 10065
      • Weill Cornell Breast Center
    • New York, New York, United States, 10016
      • Perlmutter Cancer Center
  • North Carolina
    • Asheville, North Carolina, United States, 28806
      • Hope Women's Cancer Centers
    • Asheville, North Carolina, United States, 28806
      • MH Mission Hospital, LLLP
    • Charlotte, North Carolina, United States, 28204
      • Novant Health Presbyterian Medical Center
    • Charlotte, North Carolina, United States, 28204
      • Novant Health Cancer Specialists
    • Charlotte, North Carolina, United States, 28262
      • Southern Oncology Specialists
    • Huntersville, North Carolina, United States, 28078
      • Lake Norman Hematology Oncology Specialists
    • Huntersville, North Carolina, United States, 28078
      • Novant Health Huntersville Medical Center
    • Huntersville, North Carolina, United States, 28078
      • Southern Oncology Specialists
    • Matthews, North Carolina, United States, 28105
      • Novant Health Cancer Specialists
    • Matthews, North Carolina, United States, 28105
      • Novant Health Matthews Medical Center
    • Mooresville, North Carolina, United States, 28117
      • Lake Norman Hematology Oncology Specialists
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74146
      • Oklahoma Cancer Specialists and Research Institute, LLC
  • Oregon
    • Portland, Oregon, United States, 97227
      • Northwest Cancer Specialists, P.C.
    • Portland, Oregon, United States, 97213
      • Northwest Cancer Specialists, P.C.
    • Tigard, Oregon, United States, 97223
      • Northwest Cancer Specialists, P.C.
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16505
      • UPMC Hillman Cancer Center Erie
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Womens Hospital of UPMC
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center
  • Tennessee
    • Dickson, Tennessee, United States, 37055
      • Tennessee Oncology, PLLC
    • Franklin, Tennessee, United States, 37067
      • Tennessee Oncology, PLLC
    • Gallatin, Tennessee, United States, 37066
      • Tennessee Oncology PLLC
    • Germantown, Tennessee, United States, 38138
      • The West Clinic, P.C. d/b/a West Cancer Center
    • Hermitage, Tennessee, United States, 37076
      • Tennessee Oncology, PLLC
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center
    • Lebanon, Tennessee, United States, 37090
      • Tennessee Oncology, PLLC
    • Memphis, Tennessee, United States, 38104
      • The West Clinic, P.C. d/b/a West Cancer Center
    • Murfreesboro, Tennessee, United States, 37129
      • Tennessee Oncology PLLC
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology PLLC
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37205
      • Tennessee Oncology PLLC
    • Nashville, Tennessee, United States, 37207
      • Tennessee Oncology PLLC
    • Nashville, Tennessee, United States, 37211
      • Tennessee Oncology PLLC
    • Shelbyville, Tennessee, United States, 37160
      • Tennessee Oncology, PLLC
    • Smyrna, Tennessee, United States, 37167
      • Tennessee Oncology PLLC
  • Texas
    • Arlington, Texas, United States, 76014
      • The Center for Cancer and Blood Disorders
    • Austin, Texas, United States, 78745
      • Texas Oncology-South Austin
    • Burleson, Texas, United States, 76028
      • The Center for Cancer and Blood Disorders (Huguley)
    • Cedar Park, Texas, United States, 78613
      • Texas Oncology - Cedar Park
    • Dallas, Texas, United States, 75246
      • Texas Oncology-Baylor Charles A. Sammons Cancer Center
    • El Paso, Texas, United States, 79902
      • Texas Oncology-El Paso Cancer Treatment Center Grandview
    • El Paso, Texas, United States, 79915
      • Texas Oncology-El Paso Cancer Treatment Center Gateway
    • El Paso, Texas, United States, 79938
      • Texas Oncology - El Paso Cancer Treatment Center Joe Battle
    • Fort Worth, Texas, United States, 76177
      • Investigational Products Center (IPC)
    • Fort Worth, Texas, United States, 76104
      • The Center for Cancer and Blood Disorders
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • UT MD Anderson Cancer Center
    • Houston, Texas, United States, 77024
      • Texas Oncology-Memorial City
    • Houston, Texas, United States, 77030
      • University of Texas, MD Anderson Cancer Center
    • Irving, Texas, United States, 75063
      • US Oncology Investigational Products Center (IPC)
    • Irving, Texas, United States, 75063
      • US Oncology Investigational Product Center (IPC)
    • Irving, Texas, United States, 75063
      • US Oncology Investigational Products Center(IPC)
    • Plano, Texas, United States, 75075-7787
      • Texas Oncology-Plano East
    • Round Rock, Texas, United States, 78665
      • Texas Oncology-Seton Williamson
    • Waco, Texas, United States, 76712
      • Texas Oncology - Waco
    • Waco, Texas, United States, 76712
      • Texas Oncology-Waco
    • Weatherford, Texas, United States, 76086
      • The Center for Cancer and Blood Disorders
  • Virginia
    • Alexandria, Virginia, United States, 22304
      • Virginia Cancer Specialists, PC
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists, PC
    • Newport News, Virginia, United States, 23606
      • Virginia Oncology Associates
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
    • Virginia Beach, Virginia, United States, 23456
      • Virginia Oncology Associates
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Institute
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center
    • Vancouver, Washington, United States, 98684
      • Northwest Cancer Specialists, P.C.
    • Vancouver, Washington, United States, 98683
      • Northwest Cancer Specialists, P.C.(Admin Only)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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
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
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.
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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
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

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Medivation, Inc.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2013
• Primary Completion (Actual): September 15, 2017
• Study Completion (Actual): March 5, 2021

Study Registration Dates

• First Submitted: September 11, 2013
• First Submitted That Met QC Criteria: September 16, 2013
• First Posted (Estimate): September 19, 2013

Study Record Updates

• Last Update Posted (Actual): January 20, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: PARP inhibitor; Breast cancer; BRCA mutation; BRCA 1; BRCA 2
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Poly(ADP-ribose) Polymerase Inhibitors; Talazoparib
• Other Study ID Numbers: 673-301; C3441009 (Other Identifier: Alias Study Number); 2013-002716-28 (EudraCT Number); U1111-1155-7579 (Other Identifier: Universal Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.