Spots Global Cancer Trial Database for A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study)
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Trial Identification
Brief Title: A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study)
Official Title: A PHASE 2, 2-STAGE, 2-COHORT STUDY OF TALAZOPARIB (BMN 673) ADMINISTERED TO GERMLINE BRCA MUTATION SUBJECTS WITH LOCALLY ADVANCED AND/OR METASTATIC BREAST CANCER
Study ID: NCT02034916
Interventions
Study Description
Brief Summary: The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to either Cohort 1 or 2 based on prior chemotherapy for metastatic disease: * Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for metastatic disease with disease progression \> 8 weeks following the last dose of platinum; or * Cohort 2) Subjects who have received \> 2 prior chemotherapy regimens for metastatic disease and who have had no prior platinum therapy for metastatic disease
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Marin Cancer Care, Inc., Greenbrae, California, United States
UCLA West Medical Pharmacy Attn: Steven L. Wong, PharmD, Los Angeles, California, United States
UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D., Los Angeles, California, United States
TRIO-US Central Administration, Los Angeles, California, United States
Stanford Women's Cancer Center, Palo Alto, California, United States
UCLA Hematology Oncology- Porter Ranch, Porter Ranch, California, United States
Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates, Redondo Beach, California, United States
University of California, San Francisco: Helen Diller Comprehensive Cancer Center, San Francisco, California, United States
UCLA Hematology-Oncology, Santa Monica, California, United States
Stanford Cancer Institute, Stanford, California, United States
Stanford Hospital and Clinics, Stanford, California, United States
Sylvester at Deerfield Beach, Deerfield Beach, Florida, United States
Memorial Cancer Institute at Memorial Regional Hospital, Hollywood, Florida, United States
Memorial Regional Hospital, Hollywood, Florida, United States
University of Miami Hospital & Clinics, Miami, Florida, United States
Memorial Breast Cancer Center at Memorial Hospital West, Pembroke Pines, Florida, United States
Memorial Cancer Institute at Memorial Hospital West, Pembroke Pines, Florida, United States
Memorial Hospital West, Pembroke Pines, Florida, United States
Sylvester at Plantation, Plantation, Florida, United States
ICRC, Indianapolis, Indiana, United States
Indiana University Health Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Investigational Drug Services, Indianapolis, Indiana, United States
IU Health University Hospital, Indianapolis, Indiana, United States
Sidney & Lois Eskenazi Hospital, Indianapolis, Indiana, United States
Springmill Medical Clinic, Indianapolis, Indiana, United States
Anne Arundel Medical Center (AAMC), Annapolis Oncology and Hematology, Annapolis, Maryland, United States
Anne Arundel Medical Center (AAMC), Research Pharmacy, Annapolis, Maryland, United States
Anne Arundel Medical Center (AAMC), Annapolis, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins, Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins, Green Spring Station, Lutherville, Maryland, United States
Memorial Sloan Kettering Evelyn H. Lauder Breast Center, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Memorial Sloan Kettering Rockville Centre, Rockville Centre, New York, United States
University of Tennessee Medical Center, Knoxville, Tennessee, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
The Sarah Cannon Research Institute, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Centre Oscar Lambret, Lille Cédex, , France
Centre Leon Berard, Lyon Cedex 08, , France
Institut Paoli Calmettes, Marseille, , France
Hopital Prive du Confluent, Nantes BP 20215, , 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
Universitaetsklinikum Erlangen, Erlangen, Bavaria, Germany
IOZ Muenchen - lnerdisziplinaeres Onkologisches Zentrum, Muenchen, Bavaria, Germany
Klinikum rechts der Isar der TU Muenchen, Muenchen, Bavaria, Germany
University of Munich (LMU) Grosshadern Hospital, Munich, Bavaria, Germany
Klinikum Mutterhaus Der Borromaeerinnen Ggmbh, Trier, Rheinland-pfalz, Germany
University Hospital Carl Gustav Carus, Dresden, Saxony, Germany
Helios Klinikum Berlin-Buch, Berlin, , Germany
University Hospital Duesseldorf, Duesseldorf, , Germany
Kliniken Essen Mitte Klinik fuer Gynaekologie und Gynaekologische Onkologie, Essen, , Germany
Universitaetsklinikum Schleswig-Holstein, Kiel, , Germany
g.SUND Gynaekologie Kompetenzzentrum Stralsund, Stralsund, , Germany
Universitaets-Frauenklinik, Tuebingen, , Germany
Complejo Hospitalario Universitario A Coruna, A Coruna, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Complejo Hospitalario de Jaen, Jaen, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
MD Anderson Cancer Center International Espana, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Universitario San Juan de Alicante, San Juan de Alicante, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Cambridge University Hospital NHS Foundation Trust, Cambridge, England, United Kingdom
Sarah Cannon Research Institute UK, London, England, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust, Preston, Lancashire, United Kingdom
The Royal Marsden NHS Foundation Trust, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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