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

Primary Purpose

Metastatic Breast Cancer, Locally Recurrent Breast Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Eribulin
Balixafortide
Sponsored by
Polyphor Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • California Cancer Associates for Research and Excellence
  • Cedars-Sinai Medical Center
  • UCSF Mount Zion Cancer Center
  • Stanford Cancer Center South Bay
  • Norwalk Hospital
  • Florida Cancer Specialists SOUTH - SCRI - PPDS
  • Orlando Health
  • Florida Cancer Specialists NORTH - SCRI - PPDS
  • Florida Cancer Specialists PAN - SCRI - PPDS
  • Tallahassee Memorial HealthCare
  • Florida Cancer Specialists EAST - SCRI - PPDS
  • University Cancer and Blood Center, LLC
  • Piedmont Cancer Institute PC
  • Orchard Healthcare Research Inc
  • Herbert-Herman Cancer Center, Sparrow Hospital
  • Virginia Piper Cancer Institute
  • Saint Luke's Cancer Institute 150 Entrance
  • HCA Midwest Health - SCRI - PPDS
  • Mercy Research Oncology
  • CHI Health St. Francis
  • Comprehensive Cancer Centers of Nevada
  • Queens Hospital Cancer Center
  • OHSU Knight Cancer Institute Hematology Oncology
  • Magee Women's Hospital
  • Sarah Cannon Research Institute
  • Vanderbilt University Medical Center
  • University of Vermont Medical Center
  • West Virginia University Hospital
  • Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
  • Centro de Investigación Clínica - Clínica Viedma
  • Sanatorio Parque de Rosario
  • CAIPO Centro para la atención integral del paciente oncológico
  • Grand Hopital de Charleroi asbl
  • UZ Antwerpen
  • CHIREC Centre Hospitalier Interregional Edith Cavell
  • UZ Gent
  • CHU de Liège
  • Centro de Oncologia Da Bahia
  • Universidade de Caxias do Sul (IPCEM-UCS)
  • Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
  • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
  • INCA Instituto Nacional De Cancer
  • Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto
  • Clinica de Pesquisas e Centro de Estudos Oncologia Ginecologica e Mamaria Ltda
  • Multiscan s.r.o - Onkologická ambulance
  • Fakultni nemocnice Hradec Kralove
  • Fakultni nemocnice v Motole
  • Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
  • Institut de Cancérologie de l'Ouest
  • EDOG - Institut Claudius Regaud - PPDS
  • Ospedale San Raffaele S.r.l. - PPDS
  • ASST di Monza - Azienda Ospedaliera San Gerardo
  • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
  • Azienda Ospedaliera Universitaria - Università degli studi della Campania "Luigi Vanvitelli"
  • National Cancer Center
  • Asan Medical Center
  • Samsung Medical Center
  • Ulsan University Hospital
  • LLC Evimed
  • Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy
  • Medical Center Tonus
  • Budgetary Healthcare Institution of the Omsk region "Clinical Oncology Dispensary"
  • Evromedservis LCC
  • Mordovia State University
  • Research Oncology Institute of Tomsk Scientific Center
  • Volgograd Regional Clinical Oncology Dispensary
  • Hospital Universitario Virgen Macarena
  • Hospital Universitario Germans Trias i Pujol
  • ICO l'Hospitalet - Hospital Duran i Reynals
  • Hospital Quironsalud Barcelona
  • Hospital Universitari Arnau de Vilanova
  • Hospital Universitario A Coruña
  • Hospital Universitario de Badajoz
  • Hospital Universitario Vall D'Hebrón
  • Hospital General Universitario Gregorio Marañon
  • Hospital Ruber Internacional
  • Hospital Clinico San Carlos
  • Hospital Clinico Universitario de Valencia
  • Chi Mei Medical Center, Liouying
  • Taipei Veterans General Hospital
  • Koo Foundation Sun Yat-Sen Cancer Center
  • Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS
  • LLC Medical Center Family Medicine Clinic
  • Municipal Institution SubCarpathian Clinical Oncological Centre
  • CNCE of Lviv Regional Council Lviv Oncological Regional Therapeutical and Diagnostic Centre
  • Leicester Royal Infirmary
  • Barts Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Eribulin

Balixafortide + eribulin

Arm Description

Outcomes

Primary Outcome Measures

Progression Free Survival as assessed by Independent Review Committee

Secondary Outcome Measures

Full Information

First Posted
December 20, 2018
Last Updated
November 26, 2020
Sponsor
Polyphor Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03786094
Brief Title
Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 14, 2019 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Polyphor Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer, Locally Recurrent Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
384 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eribulin
Arm Type
Active Comparator
Arm Title
Balixafortide + eribulin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Eribulin
Other Intervention Name(s)
Eribulin Injection [Halaven]
Intervention Description
Eribulin alone
Intervention Type
Drug
Intervention Name(s)
Balixafortide
Other Intervention Name(s)
POL6326
Intervention Description
balixafortide + eribulin
Primary Outcome Measure Information:
Title
Progression Free Survival as assessed by Independent Review Committee
Time Frame
12 months after last patient randomized

10. Eligibility

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

12. IPD Sharing Statement

Learn more about this trial

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

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