Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer
- Conditions
- Metastatic Breast CancerLocally Recurrent Breast Cancer
- Interventions
- Registration Number
- NCT03786094
- Lead Sponsor
- Spexis AG
- 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
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 432
- Histologically confirmed Breast cancer
- 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
Key
- Previously treated with eribulin
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Eribulin Eribulin - Balixafortide + Eribulin Eribulin - Balixafortide + Eribulin Balixafortide -
- Primary Outcome Measures
Name Time Method Progression Free Survival (2nd Line+ Population) Patients received treatment until PD by RECIST v1.1 criteria was met or until one of the treatment discontinuation or study withdrawal criteria was met. To evaluate the efficacy of balixafortide + eribulin versus eribulin monotherapy on the primary endpoint of progression free survival (PFS). PFS, as assessed by the Independent Review Committee, defined as the time from the date of randomization to the earliest evidence of documented progressive disease or death from any cause. Patients who were alive without postbaseline assessments or without documented progressive disease, lost to follow-up, withdrew consent, started an anticancer therapy prior to observing a progressive disease or with an event documented after 2 or more missing tumor assessments were censored.
PFS was evaluated according to RECIST v1.1 guidelines for complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).Progression Free Survival (3rd Line+ Population) Patients received treatment until PD by RECIST v1.1 criteria was met or until one of the treatment discontinuation or study withdrawal criteria was met. To evaluate the efficacy of balixafortide + eribulin versus eribulin monotherapy on the primary endpoint of progression free survival (PFS). PFS, as assessed by the Independent Review Committee, defined as the time from the date of randomization to the earliest evidence of documented progressive disease or death from any cause. Patients who were alive without postbaseline assessments or without documented progressive disease, lost to follow-up, withdrew consent, started an anticancer therapy prior to observing a progressive disease or with an event documented after 2 or more missing tumor assessments were censored.
PFS was evaluated according to RECIST v1.1 guidelines for complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).
- Secondary Outcome Measures
Name Time Method Overall Survival (3rd Line+ Population) The Investigator monitored the patient for OS status every 6 months (or more frequently) until: death, the patient withdrew consent to follow-up for survival, or until the patient was lost to follow-up (whichever occurred first). To compare the overall survival (OS) between patients in the balixafortide + eribulin treatment arm versus eribulin monotherapy treatment arm. OS is defined as the time from date of randomization to date of death due to any cause. Patients who are lost to follow-up or are not known to have died at the time of data-cut-off for analysis or who do not have any follow up since randomization were censored.
Trial Locations
- Locations (88)
California Cancer Associates for Research and Excellence
🇺🇸Fresno, California, United States
Tallahassee Memorial HealthCare
🇺🇸Tallahassee, Florida, United States
West Virginia University Hospital
🇺🇸Morgantown, West Virginia, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Grand Hopital de Charleroi asbl
🇧🇪Charleroi, Hainaut, Belgium
UZ Gent
🇧🇪Gent, Belgium
Volgograd Regional Clinical Oncology Dispensary
🇷🇺Volgograd, Russian Federation
LLC Evimed
🇷🇺Chelyabinsk, Russian Federation
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
UCSF Mount Zion Cancer Center
🇺🇸San Francisco, California, United States
Virginia Piper Cancer Institute
🇺🇸Minneapolis, Minnesota, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Florida Cancer Specialists SOUTH - SCRI - PPDS
🇺🇸Fort Myers, Florida, United States
CHI Health St. Francis
🇺🇸Grand Island, Nebraska, United States
Florida Cancer Specialists NORTH - SCRI - PPDS
🇺🇸Saint Petersburg, Florida, United States
Orchard Healthcare Research Inc
🇺🇸Skokie, Illinois, United States
Herbert-Herman Cancer Center, Sparrow Hospital
🇺🇸Lansing, Michigan, United States
Mercy Research Oncology
🇺🇸Saint Louis, Missouri, United States
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
🇦🇷San Juan, Buenos Aires, Argentina
Sanatorio Parque de Rosario
🇦🇷Rosario, Santa Fe, Argentina
UZ Antwerpen
🇧🇪Antwerpen, Belgium
CHIREC Centre Hospitalier Interregional Edith Cavell
🇧🇪Brussels, Belgium
CHU de Liège
🇧🇪Liège, Belgium
Centro de Oncologia Da Bahia
🇧🇷Bahia, Brazil
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
🇮🇹Bologna, Italy
Fakultni nemocnice v Motole
🇨🇿Prague, Czechia
Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto
🇧🇷São José Do Rio Preto, Brazil
Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
🇫🇷Lyon, France
Institut de Cancérologie de l'Ouest
🇫🇷Saint-Herblain, France
Ospedale San Raffaele S.r.l. - PPDS
🇮🇹Milano, Lombardia, Italy
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Andalucia, Spain
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
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 General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Chi Mei Medical Center, Liouying
🇨🇳Tainan City, Taiwan
LLC Medical Center Family Medicine Clinic
🇺🇦Dnipro, Ukraine
Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS
🇺🇦Dnipro, Ukraine
Municipal Institution SubCarpathian Clinical Oncological Centre
🇺🇦Ivano-Frankivs'k, Ukraine
Koo Foundation Sun Yat-Sen Cancer Center
🇨🇳Taipei, Taiwan
Azienda Ospedaliera Universitaria - Università degli studi della Campania "Luigi Vanvitelli"
🇮🇹Napoli, Italy
Universidade de Caxias do Sul (IPCEM-UCS)
🇧🇷Caxias Do Sul, Brazil
Hospital Ruber Internacional
🇪🇸Madrid, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Florida Cancer Specialists EAST - SCRI - PPDS
🇺🇸West Palm Beach, Florida, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Norwalk Hospital
🇺🇸Norwalk, Connecticut, United States
Florida Cancer Specialists PAN - SCRI - PPDS
🇺🇸Tallahassee, Florida, United States
University Cancer and Blood Center, LLC
🇺🇸Athens, Georgia, United States
Magee Women's Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Queens Hospital Cancer Center
🇺🇸New York, New York, United States
Vanderbilt University Medical Center
🇺🇸Tennessee, Tennessee, United States
Centro de Investigación Clínica - Clínica Viedma
🇦🇷Viedma, Río Negro, Argentina
CAIPO Centro para la atención integral del paciente oncológico
🇦🇷San Miguel De Tucumán, Argentina
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
Clinica de Pesquisas e Centro de Estudos Oncologia Ginecologica e Mamaria Ltda
🇧🇷São Paulo, Brazil
INCA Instituto Nacional De Cancer
🇧🇷Rio De Janeiro, Brazil
Fakultni nemocnice Hradec Kralove
🇨🇿Hradec Králové, Czechia
Multiscan s.r.o - Onkologická ambulance
🇨🇿Hořovice, Czechia
EDOG - Institut Claudius Regaud - PPDS
🇫🇷Toulouse, France
ASST di Monza - Azienda Ospedaliera San Gerardo
🇮🇹Monza, Milano, Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
🇮🇹Catania, Italy
National Cancer Center
🇰🇷Goyang-si, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Samsung Medical Center
🇰🇷Seul, Korea, Republic of
Hospital Universitario Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Research Oncology Institute of Tomsk Scientific Center
🇷🇺Tomsk, Russian Federation
ICO l'Hospitalet - Hospital Duran i Reynals
🇪🇸L'Hospitalet De Llobregat, Barcelona, Spain
Hospital Universitario Vall D'Hebrón
🇪🇸Barcelona, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
CNCE of Lviv Regional Council Lviv Oncological Regional Therapeutical and Diagnostic Centre
🇺🇦Lviv, Ukraine
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
Stanford Cancer Center South Bay
🇺🇸San Jose, California, United States
Piedmont Cancer Institute PC
🇺🇸Atlanta, Georgia, United States
Orlando Health
🇺🇸Orlando, Florida, United States
Saint Luke's Cancer Institute 150 Entrance
🇺🇸Kansas City, Missouri, United States
HCA Midwest Health - SCRI - PPDS
🇺🇸Kansas City, Missouri, United States
OHSU Knight Cancer Institute Hematology Oncology
🇺🇸Portland, Oregon, United States
Barts Cancer Institute
🇬🇧London, United Kingdom