Spots Global Cancer Trial Database for Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer)
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Trial Identification
Brief Title: Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer)
Official Title: A Phase 2/3, Multi-Center, Open-Label, Randomized Study of Weekly Nab®-Paclitaxel in Combination With Gemcitabine or Carboplatin, Compared to Gemcitabine/Carboplatin, as First Line Treatment in Subjects With ER, PgR, and HER2 Negative (Triple Negative) Metastatic Breast Cancer
Study ID: NCT01881230
Conditions
Study Description
Brief Summary: The purpose of this study is to compare the safety and efficacy of nab-paclitaxel in combination with either gemcitabine or carboplatin to the combination of gemcitabine and carboplatin as first line treatment in female subjects with triple negative metastatic breast cancer (TNMBC) or metastatic triple negative breast cancer.
Detailed Description: ABI-007-MBC- 001 is a Phase 2/3, multicenter, open-label, randomized, study that will compare the safety and efficacy of weekly nab-paclitaxel in combination with gemcitabine or carboplatin to the combination of gemcitabine and carboplatin as first line therapy in female subjects with Estrogen Receptor (ER), Progesterone Receptor (PgR), and human epidermal growth factor receptor 2 (HER2) negative (triple negative) metastatic breast cancer (TNMBC) or metastatic triple negative breast cancer. In the phase 2 portion of the study, the combinations of nab-paclitaxel plus gemcitabine and nab-paclitaxel plus carboplatin will be evaluated, and a comparator arm of gemcitabine combined with carboplatin will be used. In the phase 3 portion of the study, the selected nab-paclitaxel combination treatment will be compared to gemcitabine combined with carboplatin to evaluate progression free survival, safety and tolerability, overall survival, disease control rate and duration of response in women with metastatic triple negative breast cancer. Due to changes in the treatment landscape since the initiation of this trial, the decision was made not to proceed to the Phase 3 portion of the study.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Ironwood Cancer and Research Center, Chandler, Arizona, United States
Arizona Center for Cancer Care, Glendale, Arizona, United States
Arizona Cancer Research Alliance, Scottsdale, Arizona, United States
Mayo Clinic Arizona, Scottsdale, Arizona, United States
Highlands Oncology Group, Fayetteville, Arkansas, United States
Pacific Cancer Medical Center Inc, Anaheim, California, United States
California Cancer Associates for Research and Excellence cCARE, Escondido, California, United States
University of California San Diego Moores Cancer Center, La Jolla, California, United States
Wilshire Oncology Medical Group, Inc, La Verne, California, United States
Translational Research Management, Los Angeles, California, United States
Coastal Integrative Cancer Care, San Luis Obispo, California, United States
Central Coast Medical Oncology Corporation, Santa Maria, California, United States
Redwood Regional Medical Group, INC, Santa Rosa, California, United States
Center for Hematology-Oncology, Boca Raton, Florida, United States
Memorial Breast Cancer Center, Hollywood, Florida, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
University of Miami School of Medicine, Miami, Florida, United States
Florida Cancer Specialists, Saint Petersburg, Florida, United States
Florida Cancer Specialists, Sarasota, Florida, United States
Florida Cancer Specialists, West Palm Beach, Florida, United States
Joliet Oncology-Hematology Associates, Ltd, Joliet, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
Investigative Clinical Research of Indiana, LLC, Indianapolis, Indiana, United States
University of South Alabama Mitchell Cancer Institute, Lafayette, Louisiana, United States
University of Maryland School of Med, Baltimore, Maryland, United States
Center for Cancer and Blood Disorders, PC, Bethesda, Maryland, United States
Henry Ford Medical Center - New Center One, Detroit, Michigan, United States
Minnesota Oncology Hematology, PA, Minneapolis, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Midwest Physicians Group, Kansas City, Missouri, United States
Missouri Baptist Medical Center, Saint Louis, Missouri, United States
New Hampshire Oncology Hematology, Hooksett, New Hampshire, United States
Dartmouth Hitchcock Medical Center Norris Cotton Cancer Center, Lebanon, New Hampshire, United States
Englewood Hospital and Medical Center, Englewood, New Jersey, United States
Hematology Oncology Associates of CNY, East Syracuse, New York, United States
NYU Langone Arena Oncology, Lake Success, New York, United States
Clinical Research Alliance, New York, New York, United States
Alamance Regional Medical Cancer Center, Burlington, North Carolina, United States
University of Cincinnatti, Cincinnati, Ohio, United States
Oncology Hematology Care, Cincinnati, Ohio, United States
Mark H Zangmeister Center, Columbus, Ohio, United States
Toledo Community Oncology Program, Toledo, Ohio, United States
Cancer Centers of Southwest Oklahoma, Lawton, Oklahoma, United States
North Bend Medical Center, Coos Bay, Oregon, United States
Northwest Cancer Specialists, P.C. - Hoyt, Portland, Oregon, United States
Providence Portland Medical Center, Portland, Oregon, United States
St Mary Medical Center, Langhorne, Pennsylvania, United States
Magee Women's Hospital, Pittsburgh, Pennsylvania, United States
South Carolina Oncology Associates, Columbia, South Carolina, United States
Chattanooga Oncology Hematology Associates, Chattanooga, Tennessee, United States
Sarah Cannon Cancer Center, Nashville, Tennessee, United States
Texas Oncology, PA, Dallas, Texas, United States
Texas Oncology, PA- Dallas, Dallas, Texas, United States
The Center for Cancer and Blood Disorders, Fort Worth, Texas, United States
UT Physicians General Medicine, Houston, Texas, United States
Cancer Care Centers of South Texas - Loop, San Antonio, Texas, United States
Texas Oncology P.A.- Tyler, Tyler, Texas, United States
Hematology Oncology Associates of Fredericksburg, Fredericksburg, Virginia, United States
Delta Hematologyoncology Associates, Portsmouth, Virginia, United States
Virginia Cancer Institute, Richmond, Virginia, United States
Medical Oncology Associates, Spokane, Washington, United States
Edwards Comprehensive Cancer Center, Huntington, West Virginia, United States
Saint Vincent Hospital, Green Bay, Wisconsin, United States
Columbia St Marys Cancer Center, Milwaukee, Wisconsin, United States
Canberra Hospital, Garran, Australian Capital Territory, Australia
Frankston Hospital Oncology Research, Frankston, Victoria, Australia
Border Medical Oncology, Wodonga, Victoria, Australia
Sir Charles Gairdner Hospital, Nedlands, , Australia
Universitaetsklinik Innsbruck, Innsbruck, , Austria
Salzburger Landkliniken St. Johanns-Spital, Salzburg, , Austria
Medizinische Universitat Wien, Vienna, , Austria
Centro de Oncologia Da Bahia, Salvador, Bahia, Brazil
Liga Paranaense de Combate Ao Cancer, Curitiba, Paraná, Brazil
Instituto Nacional de Cancer - INCA, Rio De Janerio, Rio De Janeiro, Brazil
Associacao Hospitalar Moinhos de Vento Hospital Moinhos de Vento, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Sao Lucas - PUCRS, Porto Alegre, Rio Grande Do Sul, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos, Barretos, São Paulo, Brazil
Hospital Dr. Amaral Carvalho/ Hospital Amaral Carvalho Jaú, Jau/SP, São Paulo, Brazil
ONCOCLINIC Clinica de Oncologia LTDA, Fortaleza, , Brazil
Instituto Ribeiraopretano de Combate Ao Cancer, Ribeirao Preto, , Brazil
Hospital das Clinicas da Faculdade de Medicina da USP, Ribeirao Preto, , Brazil
Hospital Bruno Born, Rio Grande Do Sul, , Brazil
Hospital de Base Da Faculdade de Medicina de, Sao Jose Do Rio Preto, , Brazil
Hospital Albert Einstein Sociedade Beneficente Israelita Brasileira, Sao Paulo, , Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes, São Paulo, , Brazil
Instituto Brasileiro de Controle Do Cancer IBCC, São Paulo, , Brazil
Ottawa General Hospital, Ottawa, Ontario, Canada
CHUM - Notre Dame, Montreal, Quebec, Canada
Hospital du Saint Scarement Sacrement Laboratory, Quebec City, Quebec, Canada
CSSS de Rimouski Neigette, Rimouski, Quebec, Canada
Alan Blair Cancer Centre at Pasqua Hosptial, Regina, Saskatchewan, Canada
Centre Jean Perrin, Clermont-Ferrand, , France
Sankt Gertrauden-Krankenhaus, Berlin, , Germany
Facharztpraxis fur Gynakologie und Geburtshilfe, Bonn, , Germany
Agaplesion Markus Krankenhaus, Frankfurt, , Germany
Praxis fur interdisziplinare Onkologie & Hamatologie, Freiburg, , Germany
Universitaetsklinikum Heidelberg, Heidelberg, , Germany
Frauenarzte am Bahnhofsplatz, Hildesheim, , Germany
Schwerpunktpraxis fur Gynakologische Onkologie, Köln, , Germany
LMU Klinikum der Universitat, München, , Germany
Krankenanstalt Mutterhaus der Borromaerinnen, Trier, , Germany
Universitatsklinikum Ulm, Ulm, , Germany
University of Athens Medical school - Regional General Hospital, Athens, , Greece
IASO General, Athens, , Greece
Metropolitan Hospital, Faliro, , Greece
University General Hospital of Heraklion, Heraklion, , Greece
University General Hospital of Patras, Rio Patras, , Greece
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi, Bologna, Emilia-Romagna, , Italy
Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant' Anna, Ferrara, , Italy
IRCCS AziendaOspedaliera Universitaria San Martino, Genova, , Italy
Presidio Ospedaliero della Misericordia, Grosseto, , Italy
Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte, Messina, , Italy
Azienda Ospedaliera San Gerardo, Monza, , Italy
Azienda Ospedaliera Universitaria Federico II, Napoli, Campania, , Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale, Napoli, Campania, , Italy
Istituto Oncologico Veneto, Padova, , Italy
Arcispedale Santa Maria Nuova, Reggio Emilia, , Italy
Policlinico Universitario A Gemelli, Roma, , Italy
Azienda Ospedaliera Sant Andrea, Roma, , Italy
Istituto Nazionale Tumori Regina Elena, Roma, , Italy
Istituto Clinico Humanitas, Rozzano (MI), , Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino, Torino, Piemonte, , Italy
Azienda Ospedaliera Treviglio-Caravaggio, Treviglio, , Italy
Hospital Espirito Santo, Evora, , Portugal
Hospital Da Luz, Lisboa, , Portugal
Hospital de Santa Maria, Lisboa, , Portugal
Instituto Portugues de Oncologia do Porto, Francisco Gentil, Porto, , Portugal
Clinic Barcelona Hospital Universitari, Barcelona, , Spain
Hospital Universitario Vall D Hebron, Barcelona, , Spain
Hospital Universitario Reina Sofia, Cordoba, , Spain
Hospital General Gregorio Maranon, Madrid, , Spain
Onkologikoa - Kutxaren Institutu Onkologikoa, San Sebastian, , Spain
Hospital Clinico Universitario de Santiago, Santiago de Compostela, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Royal United Hospital, Bath, , United Kingdom
Sarah Cannon Research Institute UK, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
The East and North Hertfordshire NHS Trust, Middlesex, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield South Yorkshire, , United Kingdom
Contact Details
Name: Ileana Elias, M.D.
Affiliation: Celgene Corporation
Role: STUDY_DIRECTOR
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