Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

— FORTRESS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03786094
• Other study ID #: POL6326-009
• Status: Terminated
• Phase: Phase 3
• Start date: May 30, 2019
• Est. completion date: October 19, 2021

Study information

• Verified date: October 2023
• Source: Spexis AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 432
• Est. completion date: October 19, 2021
• Est. primary completion date: October 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Locally Recurrent Breast Cancer
• Metastatic Breast Cancer
• Recurrence

Intervention

Drug:
• Eribulin
Eribulin alone
• Balixafortide
Balixafortide + Eribulin

Locations

Country	Name	City	State
Argentina	Sanatorio Parque de Rosario	Rosario	Santa Fe
Argentina	Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan	San Juan	Buenos Aires
Argentina	CAIPO Centro para la atención integral del paciente oncológico	San Miguel De Tucumán
Argentina	Centro de Investigación Clínica - Clínica Viedma	Viedma	Río Negro
Belgium	UZ Antwerpen	Antwerpen
Belgium	CHIREC Centre Hospitalier Interregional Edith Cavell	Brussels
Belgium	Grand Hopital de Charleroi asbl	Charleroi	Hainaut
Belgium	UZ Gent	Gent
Belgium	CHU de Liège	Liège
Brazil	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
Czechia	Multiscan s.r.o - Onkologická ambulance	Horovice
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Králové
Czechia	Fakultni nemocnice v Motole	Prague
France	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
Italy	Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi	Bologna
Italy	Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele	Catania
Italy	Ospedale San Raffaele S.r.l. - PPDS	Milano	Lombardia
Italy	ASST di Monza - Azienda Ospedaliera San Gerardo	Monza	Milano
Italy	Azienda Ospedaliera Universitaria - Università degli studi della Campania "Luigi Vanvitelli"	Napoli
Korea, Republic of	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
Russian Federation	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
Spain	Hospital Universitario A Coruña	A Coruña
Spain	Hospital Universitario de Badajoz	Badajoz
Spain	Hospital Universitario Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Quironsalud Barcelona	Barcelona	Cataluña
Spain	Hospital Universitario Vall D'Hebrón	Barcelona
Spain	ICO l'Hospitalet - Hospital Duran i Reynals	L'Hospitalet De Llobregat	Barcelona
Spain	Hospital Universitari Arnau de Vilanova	Lleida	Cataluña
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Ruber Internacional	Madrid
Spain	Hospital Universitario Virgen Macarena	Sevilla	Andalucia
Spain	Hospital Clinico Universitario de Valencia	Valencia
Taiwan	Chi Mei Medical Center, Liouying	Tainan City
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Ukraine	LLC Medical Center Family Medicine Clinic	Dnipro
Ukraine	Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS	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
United Kingdom	Leicester Royal Infirmary	Leicester
United Kingdom	Barts Cancer Institute	London
United States	University Cancer and Blood Center, LLC	Athens	Georgia
United States	Piedmont Cancer Institute PC	Atlanta	Georgia
United States	University of Vermont Medical Center	Burlington	Vermont
United States	Florida Cancer Specialists SOUTH - SCRI - PPDS	Fort Myers	Florida
United States	California Cancer Associates for Research and Excellence	Fresno	California
United States	CHI Health St. Francis	Grand Island	Nebraska
United States	HCA Midwest Health - SCRI - PPDS	Kansas City	Missouri
United States	Saint Luke's Cancer Institute 150 Entrance	Kansas City	Missouri
United States	Herbert-Herman Cancer Center, Sparrow Hospital	Lansing	Michigan
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Virginia Piper Cancer Institute	Minneapolis	Minnesota
United States	West Virginia University Hospital	Morgantown	West Virginia
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Queens Hospital Cancer Center	New York	New York
United States	Norwalk Hospital	Norwalk	Connecticut
United States	Orlando Health	Orlando	Florida
United States	Magee Women's Hospital	Pittsburgh	Pennsylvania
United States	OHSU Knight Cancer Institute Hematology Oncology	Portland	Oregon
United States	Mercy Research Oncology	Saint Louis	Missouri
United States	Florida Cancer Specialists NORTH - SCRI - PPDS	Saint Petersburg	Florida
United States	UCSF Mount Zion Cancer Center	San Francisco	California
United States	Stanford Cancer Center South Bay	San Jose	California
United States	Orchard Healthcare Research Inc	Skokie	Illinois
United States	Florida Cancer Specialists PAN - SCRI - PPDS	Tallahassee	Florida
United States	Tallahassee Memorial HealthCare	Tallahassee	Florida
United States	Vanderbilt University Medical Center	Tennessee	Tennessee
United States	Florida Cancer Specialists EAST - SCRI - PPDS	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Spexis AG

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Czechia,  France,  Italy,  Korea, Republic of,  Russian Federation,  Spain,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (2nd Line+ Population)	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).	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.
Primary	Progression Free Survival (3rd Line+ Population)	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).	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	Overall Survival (3rd Line+ Population)	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.	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).