Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer
NCT ID: NCT03786094
Last Updated: 2023-11-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
432 participants
INTERVENTIONAL
2019-05-30
2021-10-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Eribulin
Eribulin
Eribulin alone
Balixafortide + Eribulin
Eribulin
Eribulin alone
Balixafortide
Balixafortide + Eribulin
Interventions
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Eribulin
Eribulin alone
Balixafortide
Balixafortide + Eribulin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Metastatic Breast Cancer currently of stage IV disease or unresectable locoregionally recurrent breast cancer
* refractory to the most recent chemotherapy, documented by progression on or within six (6) months of therapy
* At least 14 days from the completion of any previous cancer therapy
* Adequate organ function
* Life expectancy of 3 months or more
* Willing and able to comply with the protocol and able to understand and willing to sign an informed consent
Exclusion Criteria
* Peripheral neuropathy Grade ≥3
* Receipt of prior CXCR4 therapy
* Receipt of colony stimulating factors (CSFs) filgrastim, pegfilgrastim, or sargramostim, or radiation therapy within 14 days prior to study Day 1
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to balixafortide or eribulin or other agents used in the study
* Breast feeding or pregnant
* Patients with congestive heart failure, electrolyte abnormalities, bradyarrhythmias, known congenital long QT syndrome, QT interval corrected with Fridericia's formula (QTcF) ≥470 msec at baseline in the absence of bundle branch block, or currently taking drugs at known risk of prolonging the QT interval or causing torsades de pointes
18 Years
ALL
No
Sponsors
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Spexis AG
INDUSTRY
Responsible Party
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Principal Investigators
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François Ringeisen, MD
Role: STUDY_DIRECTOR
Polyphor Ltd.
Peter A Kaufman, MD
Role: PRINCIPAL_INVESTIGATOR
UVM medical center; USA
Javier Cortes, MD
Role: PRINCIPAL_INVESTIGATOR
IOB and VHIO; Spain
Locations
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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
St. 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
St 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 City, 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 Province, Argentina
Sanatorio Parque de Rosario
Rosario, Santa Fe Province, 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
Antwerp, , Belgium
CHIREC Centre Hospitalier Interregional Edith Cavell
Brussels, , Belgium
UZ Gent
Ghent, , 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
Milan, Lombardy, 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
LLC Evimed
Chelyabinsk, , Russia
Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy
Krasnoyarsk, , Russia
Medical Center Tonus
Nizhny Novgorod, , Russia
Budgetary Healthcare Institution of the Omsk region "Clinical Oncology Dispensary"
Omsk, , Russia
Evromedservis LCC
Pushkin, , Russia
Mordovia State University
Saransk, , Russia
Research Oncology Institute of Tomsk Scientific Center
Tomsk, , Russia
Volgograd Regional Clinical Oncology Dispensary
Volgograd, , Russia
National Cancer Center
Goyang-si, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Hospital Universitario Virgen Macarena
Seville, Andalusia, 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, Catalonia, Spain
Hospital Universitari Arnau de Vilanova
Lleida, Catalonia, 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-Frankivsk, , 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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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POL6326-009
Identifier Type: -
Identifier Source: org_study_id
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