Spots Global Cancer Trial Database for Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer
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Trial Identification
Brief Title: Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer
Official Title: An International, Phase 3, Multicenter, Randomized, Open- Label Trial Comparing Balixafortide in Combination With Eribulin Versus Eribulin Alone in Patients With HER2 Negative, Locally Recurrent or Metastatic Breast Cancer
Study ID: NCT03786094
Study Description
Brief Summary: This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment of HER2 negative, Locally Recurrent or Metastatic Breast Cancer.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
California Cancer Associates for Research and Excellence, Fresno, California, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
UCSF Mount Zion Cancer Center, San Francisco, California, United States
Stanford Cancer Center South Bay, San Jose, California, United States
Norwalk Hospital, Norwalk, Connecticut, United States
Florida Cancer Specialists SOUTH - SCRI - PPDS, Fort Myers, Florida, United States
Orlando Health, Orlando, Florida, United States
Florida Cancer Specialists NORTH - SCRI - PPDS, Saint Petersburg, Florida, United States
Florida Cancer Specialists PAN - SCRI - PPDS, Tallahassee, Florida, United States
Tallahassee Memorial HealthCare, Tallahassee, Florida, United States
Florida Cancer Specialists EAST - SCRI - PPDS, West Palm Beach, Florida, United States
University Cancer and Blood Center, LLC, Athens, Georgia, United States
Piedmont Cancer Institute PC, Atlanta, Georgia, United States
Orchard Healthcare Research Inc, Skokie, Illinois, United States
Herbert-Herman Cancer Center, Sparrow Hospital, Lansing, Michigan, United States
Virginia Piper Cancer Institute, Minneapolis, Minnesota, United States
Saint Luke's Cancer Institute 150 Entrance, Kansas City, Missouri, United States
HCA Midwest Health - SCRI - PPDS, Kansas City, Missouri, United States
Mercy Research Oncology, Saint Louis, Missouri, United States
CHI Health St. Francis, Grand Island, Nebraska, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Queens Hospital Cancer Center, New York, New York, United States
OHSU Knight Cancer Institute Hematology Oncology, Portland, Oregon, United States
Magee Women's Hospital, Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Vanderbilt University Medical Center, Tennessee, Tennessee, United States
University of Vermont Medical Center, Burlington, Vermont, United States
West Virginia University Hospital, Morgantown, West Virginia, United States
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan, San Juan, Buenos Aires, Argentina
Centro de Investigación Clínica - Clínica Viedma, Viedma, Río Negro, Argentina
Sanatorio Parque de Rosario, Rosario, Santa Fe, Argentina
CAIPO Centro para la atención integral del paciente oncológico, San Miguel De Tucumán, , Argentina
Grand Hopital de Charleroi asbl, Charleroi, Hainaut, Belgium
UZ Antwerpen, Antwerpen, , Belgium
CHIREC Centre Hospitalier Interregional Edith Cavell, Brussels, , Belgium
UZ Gent, Gent, , Belgium
CHU de Liège, Liège, , Belgium
Centro de Oncologia Da Bahia, Bahia, , Brazil
Universidade de Caxias do Sul (IPCEM-UCS), Caxias Do Sul, , Brazil
Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner, Curitiba, , Brazil
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS), Porto Alegre, , Brazil
INCA Instituto Nacional De Cancer, Rio De Janeiro, , Brazil
Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto, São José Do Rio Preto, , Brazil
Clinica de Pesquisas e Centro de Estudos Oncologia Ginecologica e Mamaria Ltda, São Paulo, , Brazil
Multiscan s.r.o - Onkologická ambulance, Hořovice, , Czechia
Fakultni nemocnice Hradec Kralove, Hradec Králové, , Czechia
Fakultni nemocnice v Motole, Prague, , Czechia
Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes, Lyon, , France
Institut de Cancérologie de l'Ouest, Saint-Herblain, , France
EDOG - Institut Claudius Regaud - PPDS, Toulouse, , France
Ospedale San Raffaele S.r.l. - PPDS, Milano, Lombardia, Italy
ASST di Monza - Azienda Ospedaliera San Gerardo, Monza, Milano, Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi, Bologna, , Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele, Catania, , Italy
Azienda Ospedaliera Universitaria - Università degli studi della Campania "Luigi Vanvitelli", Napoli, , Italy
National Cancer Center, Goyang-si, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seul, , Korea, Republic of
Ulsan University Hospital, Ulsan, , Korea, Republic of
LLC Evimed, Chelyabinsk, , Russian Federation
Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy, Krasnoyarsk, , Russian Federation
Medical Center Tonus, Nizhny Novgorod, , Russian Federation
Budgetary Healthcare Institution of the Omsk region "Clinical Oncology Dispensary", Omsk, , Russian Federation
Evromedservis LCC, Pushkin, , Russian Federation
Mordovia State University, Saransk, , Russian Federation
Research Oncology Institute of Tomsk Scientific Center, Tomsk, , Russian Federation
Volgograd Regional Clinical Oncology Dispensary, Volgograd, , Russian Federation
Hospital Universitario Virgen Macarena, Sevilla, Andalucia, Spain
Hospital Universitario Germans Trias i Pujol, Badalona, Barcelona, Spain
ICO l'Hospitalet - Hospital Duran i Reynals, L'Hospitalet De Llobregat, Barcelona, Spain
Hospital Quironsalud Barcelona, Barcelona, Cataluña, Spain
Hospital Universitari Arnau de Vilanova, Lleida, Cataluña, Spain
Hospital Universitario A Coruña, A Coruña, , Spain
Hospital Universitario de Badajoz, Badajoz, , Spain
Hospital Universitario Vall D'Hebrón, Barcelona, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Hospital Ruber Internacional, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Chi Mei Medical Center, Liouying, Tainan City, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center, Taipei, , Taiwan
Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS, Dnipro, , Ukraine
LLC Medical Center Family Medicine Clinic, Dnipro, , Ukraine
Municipal Institution SubCarpathian Clinical Oncological Centre, Ivano-Frankivs'k, , Ukraine
CNCE of Lviv Regional Council Lviv Oncological Regional Therapeutical and Diagnostic Centre, Lviv, , Ukraine
Leicester Royal Infirmary, Leicester, , United Kingdom
Barts Cancer Institute, London, , United Kingdom
Contact Details
Name: François Ringeisen, MD
Affiliation: Polyphor Ltd.
Role: STUDY_DIRECTOR
Name: Peter A Kaufman, MD
Affiliation: UVM medical center; USA
Role: PRINCIPAL_INVESTIGATOR
Name: Javier Cortes, MD
Affiliation: IOB and VHIO; Spain
Role: PRINCIPAL_INVESTIGATOR
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