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

Sponsor
Polyphor Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03786094
Collaborator
(none)
384
Enrollment
88
Locations
2
Arms
32.6
Anticipated Duration (Months)
4.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
384 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 14, 2019
Anticipated Primary Completion Date :
Mar 1, 2021
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival as assessed by Independent Review Committee [12 months after last patient randomized]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Polyphor Ltd.

    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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Polyphor Ltd.
    ClinicalTrials.gov Identifier:
    NCT03786094
    Other Study ID Numbers:
    • POL6326-009
    First Posted:
    Dec 24, 2018
    Last Update Posted:
    Nov 30, 2020
    Last Verified:
    Nov 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Recurrence

    Study Results

    No Results Posted as of Nov 30, 2020