Clinical trial NCT03786094: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Metastatic Breast Cancer
Locally Recurrent Breast Cancer
Lead sponsor: Spexis AG
Sponsor class: INDUSTRY
First posted: 2018-12-24
Enrollment: 432
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

* 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 Exclusion Criteria:

* 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

Primary outcomes:
measure: Progression Free Survival (2nd Line+ Population)
timeFrame: 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.
measure: Progression Free Survival (3rd Line+ Population)
timeFrame: 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.
Secondary outcomes:
measure: Overall Survival (3rd Line+ Population)
timeFrame: 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).
Other outcomes:
Locations:
city: Fresno
country: United States
facility: California Cancer Associates for Research and Excellence
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: San Francisco
country: United States
facility: UCSF Mount Zion Cancer Center
state: California
city: San Jose
country: United States
facility: Stanford Cancer Center South Bay
state: California
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
city: Fort Myers
country: United States
facility: Florida Cancer Specialists SOUTH - SCRI - PPDS
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists NORTH - SCRI - PPDS
state: Florida
city: Tallahassee
country: United States
facility: Florida Cancer Specialists PAN - SCRI - PPDS
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial HealthCare
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists EAST - SCRI - PPDS
state: Florida
city: Athens
country: United States
facility: University Cancer and Blood Center, LLC
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Cancer Institute PC
state: Georgia
city: Skokie
country: United States
facility: Orchard Healthcare Research Inc
state: Illinois
city: Lansing
country: United States
facility: Herbert-Herman Cancer Center, Sparrow Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Virginia Piper Cancer Institute
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Cancer Institute 150 Entrance
state: Missouri
city: Kansas City
country: United States
facility: HCA Midwest Health - SCRI - PPDS
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Research Oncology
state: Missouri
city: Grand Island
country: United States
facility: CHI Health St. Francis
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: New York
country: United States
facility: Queens Hospital Cancer Center
state: New York
city: Portland
country: United States
facility: OHSU Knight Cancer Institute Hematology Oncology
state: Oregon
city: Pittsburgh
country: United States
facility: Magee Women's Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Tennessee
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
city: San Juan
country: Argentina
facility: Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
state: Buenos Aires
city: Viedma
country: Argentina
facility: Centro de Investigación Clínica - Clínica Viedma
state: Río Negro
city: Rosario
country: Argentina
facility: Sanatorio Parque de Rosario
state: Santa Fe
city: San Miguel De Tucumán
country: Argentina
facility: CAIPO Centro para la atención integral del paciente oncológico
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi asbl
state: Hainaut
city: Antwerpen
country: Belgium
facility: UZ Antwerpen
city: Brussels
country: Belgium
facility: CHIREC Centre Hospitalier Interregional Edith Cavell
city: Gent
country: Belgium
facility: UZ Gent
city: Liège
country: Belgium
facility: CHU de Liège
city: Bahia
country: Brazil
facility: Centro de Oncologia Da Bahia
city: Caxias Do Sul
country: Brazil
facility: Universidade de Caxias do Sul (IPCEM-UCS)
city: Curitiba
country: Brazil
facility: Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
city: Rio De Janeiro
country: Brazil
facility: INCA Instituto Nacional De Cancer
city: São José Do Rio Preto
country: Brazil
facility: Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto
city: São Paulo
country: Brazil
facility: Clinica de Pesquisas e Centro de Estudos Oncologia Ginecologica e Mamaria Ltda
city: Hořovice
country: Czechia
facility: Multiscan s.r.o - Onkologická ambulance
city: Hradec Králové
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Prague
country: Czechia
facility: Fakultni nemocnice v Motole
city: Lyon
country: France
facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest
city: Toulouse
country: France
facility: EDOG - Institut Claudius Regaud - PPDS
city: Milano
country: Italy
facility: Ospedale San Raffaele S.r.l. - PPDS
state: Lombardia
city: Monza
country: Italy
facility: ASST di Monza - Azienda Ospedaliera San Gerardo
state: Milano
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria - Università degli studi della Campania "Luigi Vanvitelli"
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seul
country: Korea, Republic of
facility: Samsung Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Chelyabinsk
country: Russian Federation
facility: LLC Evimed
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy
city: Nizhny Novgorod
country: Russian Federation
facility: Medical Center Tonus
city: Omsk
country: Russian Federation
facility: Budgetary Healthcare Institution of the Omsk region "Clinical Oncology Dispensary"
city: Pushkin
country: Russian Federation
facility: Evromedservis LCC
city: Saransk
country: Russian Federation
facility: Mordovia State University
city: Tomsk
country: Russian Federation
facility: Research Oncology Institute of Tomsk Scientific Center
city: Volgograd
country: Russian Federation
facility: Volgograd Regional Clinical Oncology Dispensary
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
state: Andalucia
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Barcelona
city: L'Hospitalet De Llobregat
country: Spain
facility: ICO l'Hospitalet - Hospital Duran i Reynals
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Quironsalud Barcelona
state: Cataluña
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
state: Cataluña
city: A Coruña
country: Spain
facility: Hospital Universitario A Coruña
city: Badajoz
country: Spain
facility: Hospital Universitario de Badajoz
city: Barcelona
country: Spain
facility: Hospital Universitario Vall D'Hebrón
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Ruber Internacional
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Tainan City
country: Taiwan
facility: Chi Mei Medical Center, Liouying
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center
city: Dnipro
country: Ukraine
facility: Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS
city: Dnipro
country: Ukraine
facility: LLC Medical Center Family Medicine Clinic
city: Ivano-Frankivs'k
country: Ukraine
facility: Municipal Institution SubCarpathian Clinical Oncological Centre
city: Lviv
country: Ukraine
facility: CNCE of Lviv Regional Council Lviv Oncological Regional Therapeutical and Diagnostic Centre
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Barts Cancer Institute
Study officials:
affiliation: Polyphor Ltd.
name: François Ringeisen, MD
role: STUDY_DIRECTOR
affiliation: UVM medical center; USA
name: Peter A Kaufman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IOB and VHIO; Spain
name: Javier Cortes, MD
role: PRINCIPAL_INVESTIGATOR
References: