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

October 30, 2023 updated by: Spexis AG

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

432

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • San Miguel De Tucumán, Argentina, 4000
        • CAIPO Centro para la Atencion Integral del Paciente Oncologico
    • Buenos Aires
      • San Juan, Buenos Aires, Argentina, J5402DIL
        • Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan
    • Río Negro
      • Viedma, Río Negro, Argentina, 8500
        • Centro de Investigación Clínica - Clínica Viedma
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000
        • Sanatorio Parque de Rosario
  • Belgium
      • Antwerpen, Belgium, 2650
        • UZ Antwerpen
      • Brussels, Belgium, 1160
        • CHIREC Centre Hospitalier Interregional Edith Cavell
      • Gent, Belgium, 9000
        • UZ Gent
      • Liège, Belgium, 4000
        • CHU de Liège
    • Hainaut
      • Charleroi, Hainaut, Belgium, 6000
        • Grand Hopital de Charleroi asbl
  • Brazil
      • Bahia, Brazil, 41820-021
        • Centro de Oncologia Da Bahia
      • Caxias Do Sul, Brazil, 95070-560
        • Universidade de Caxias do Sul (IPCEM-UCS)
      • Curitiba, Brazil, 81520-060
        • Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
      • Porto Alegre, Brazil, 90610-000
        • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
      • Rio De Janeiro, Brazil, 20560-120
        • INCA Instituto Nacional de Cancer
      • São José Do Rio Preto, Brazil, 15090-000
        • Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto
      • São Paulo, Brazil, 01317-001
        • Clinica de Pesquisas e Centro de Estudos Oncologia Ginecologica e Mamaria Ltda
  • Czechia
      • Hořovice, Czechia, 28831
        • Multiscan s.r.o - Onkologická ambulance
      • Hradec Králové, Czechia, 50005
        • Fakultni nemocnice Hradec Kralove
      • Prague, Czechia, 15000
        • Fakultni nemocnice v Motole
  • France
      • Lyon, France, 69008
        • Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
      • Saint-Herblain, France, 44800
        • Institut de Cancérologie de l'Ouest
      • Toulouse, France, 31100
        • EDOG - Institut Claudius Regaud - PPDS
  • Italy
      • Bologna, Italy, 40138
        • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
      • Catania, Italy, 95123
        • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
      • Napoli, Italy, 80131
        • Azienda Ospedaliera Universitaria - Università degli studi della Campania "Luigi Vanvitelli"
    • Lombardia
      • Milano, Lombardia, Italy, 20132
        • Ospedale San Raffaele S.r.l. - PPDS
    • Milano
      • Monza, Milano, Italy, 20900
        • ASST di Monza - Azienda Ospedaliera San Gerardo
  • Korea, Republic of
      • Goyang-si, Korea, Republic of, 10408
        • National Cancer Center
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Ulsan, Korea, Republic of, 44033
        • Ulsan University Hospital
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454048
        • LLC Evimed
      • Krasnoyarsk, Russian Federation, 191024
        • Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy
      • Nizhny Novgorod, Russian Federation, 603089
        • Medical Center Tonus
      • Omsk, Russian Federation, 644013
        • Budgetary Healthcare Institution of the Omsk region "Clinical Oncology Dispensary"
      • Pushkin, Russian Federation, 196603
        • Evromedservis LCC
      • Saransk, Russian Federation, 430000
        • Mordovia State University
      • Tomsk, Russian Federation, 634009
        • Research Oncology Institute of Tomsk Scientific Center
      • Volgograd, Russian Federation, 400138
        • Volgograd Regional Clinical Oncology Dispensary
  • Spain
      • A Coruña, Spain, 15006
        • Hospital Universitario A Coruña
      • Badajoz, Spain, 06006
        • Hospital Universitario de Badajoz
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain, 28034
        • Hospital Ruber Internacional
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
    • Andalucia
      • Sevilla, Andalucia, Spain, 41009
        • Hospital Universitario Virgen Macarena
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol
      • L'Hospitalet De Llobregat, Barcelona, Spain, 08908
        • Ico L'Hospitalet - Hospital Duran I Reynals
    • Cataluña
      • Barcelona, Cataluña, Spain, 8023
        • Hospital Quironsalud Barcelona
      • Lleida, Cataluña, Spain, 25198
        • Hospital Universitari Arnau de Vilanova
  • Taiwan
      • Tainan City, Taiwan, 736
        • Chi Mei Medical Center, Liouying
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 11259
        • Koo Foundation Sun Yat-Sen Cancer Center
  • Ukraine
      • Dnipro, Ukraine, 49102
        • Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS
      • Dnipro, Ukraine, 49600
        • LLC Medical Center Family Medicine Clinic
      • Ivano-Frankivs'k, Ukraine, 76018
        • Municipal Institution SubCarpathian Clinical Oncological Centre
      • Lviv, Ukraine, 79031
        • CNCE of Lviv Regional Council Lviv Oncological Regional Therapeutical and Diagnostic Centre
  • United Kingdom
      • Leicester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • London, United Kingdom, EC1A 7BE
        • Barts Cancer Institute
  • United States
    • California
      • Fresno, California, United States, 93720
        • California Cancer Associates for Research and Excellence
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • San Francisco, California, United States, 94115
        • UCSF Mount Zion Cancer Center
      • San Jose, California, United States, 95124
        • Stanford Cancer Center South Bay
    • Connecticut
      • Norwalk, Connecticut, United States, 06856
        • Norwalk Hospital
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists South - SCRI - PPDS
      • Orlando, Florida, United States, 32806
        • Orlando Health
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists NORTH - SCRI - PPDS
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Memorial HealthCare
      • Tallahassee, Florida, United States, 32308
        • Florida Cancer Specialists PAN - SCRI - PPDS
      • West Palm Beach, Florida, United States, 33401
        • Florida Cancer Specialists EAST - SCRI - PPDS
    • Georgia
      • Athens, Georgia, United States, 30607
        • University Cancer and Blood Center, LLC
      • Atlanta, Georgia, United States, 30318
        • Piedmont Cancer Institute PC
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Orchard Healthcare Research Inc
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Herbert-Herman Cancer Center, Sparrow Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Virginia Piper Cancer Institute
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • HCA Midwest Health - SCRI - PPDS
      • Kansas City, Missouri, United States, 63376
        • Saint Luke's Cancer Institute 150 Entrance
      • Saint Louis, Missouri, United States, 63141
        • Mercy Research Oncology
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • CHI Health St. Francis
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada
    • New York
      • New York, New York, United States, 11432
        • Queens Hospital Cancer Center
    • Oregon
      • Portland, Oregon, United States, 97210
        • OHSU Knight Cancer Institute Hematology Oncology
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee Women's Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
      • Tennessee, Tennessee, United States, 37204
        • Vanderbilt University Medical Center
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Eribulin
Drug: Eribulin
Eribulin alone
Other Names:
  • Eribulin Injection [Halaven]
Experimental: Balixafortide + Eribulin
Drug: Eribulin
Eribulin alone
Other Names:
  • Eribulin Injection [Halaven]
Drug: Balixafortide
Balixafortide + Eribulin
Other Names:
  • POL6326

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (2nd Line+ Population)
Time Frame: 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).
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.
Progression Free Survival (3rd Line+ Population)
Time Frame: 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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (3rd Line+ Population)
Time Frame: 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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spexis AG

Investigators

  • Study Director: François Ringeisen, MD, Polyphor Ltd.
  • Principal Investigator: Peter A Kaufman, MD, UVM medical center; USA
  • Principal Investigator: Javier Cortes, MD, IOB and VHIO; Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2019

Primary Completion (Actual)

October 19, 2021

Study Completion (Actual)

October 19, 2021

Study Registration Dates

First Submitted

December 20, 2018

First Submitted That Met QC Criteria

December 20, 2018

First Posted (Actual)

December 24, 2018

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POL6326-009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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