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

NCT03786094 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: POL6326-009
• Study Type: interventional
• Target: 432
• Locations: 13 countries
• Sites: 88

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.

Conditions

Metastatic Breast Cancer; Locally Recurrent Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (1)

• Overall Survival (3rd Line+ Population)

  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).

Study Arms (2)

Eribulin

ACTIVE COMPARATOR

Drug: Eribulin

Balixafortide + Eribulin

EXPERIMENTAL

Drug: Eribulin; Drug: Balixafortide

Interventions

Eribulin DRUG

Eribulin alone

Also known as: Eribulin Injection [Halaven]

Balixafortide + Eribulin; Eribulin

Balixafortide DRUG

Balixafortide + Eribulin

Also known as: POL6326

Balixafortide + Eribulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spexis AG: lead

Study Sites (88)

California Cancer Associates for Research and Excellence

Fresno, California, 93720, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

UCSF Mount Zion Cancer Center

San Francisco, California, 94115, United States

Location

Stanford Cancer Center South Bay

San Jose, California, 95124, United States

Location

Norwalk Hospital

Norwalk, Connecticut, 06856, United States

Location

Florida Cancer Specialists SOUTH - SCRI - PPDS

Fort Myers, Florida, 33901, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

Florida Cancer Specialists NORTH - SCRI - PPDS

St. Petersburg, Florida, 33705, United States

Location

Florida Cancer Specialists PAN - SCRI - PPDS

Tallahassee, Florida, 32308, United States

Location

Tallahassee Memorial HealthCare

Tallahassee, Florida, 32308, United States

Location

Florida Cancer Specialists EAST - SCRI - PPDS

West Palm Beach, Florida, 33401, United States

Location

University Cancer and Blood Center, LLC

Athens, Georgia, 30607, United States

Location

Piedmont Cancer Institute PC

Atlanta, Georgia, 30318, United States

Location

Orchard Healthcare Research Inc

Skokie, Illinois, 60077, United States

Location

Herbert-Herman Cancer Center, Sparrow Hospital

Lansing, Michigan, 48912, United States

Location

Virginia Piper Cancer Institute

Minneapolis, Minnesota, 55407, United States

Location

Saint Luke's Cancer Institute 150 Entrance

Kansas City, Missouri, 63376, United States

Location

HCA Midwest Health - SCRI - PPDS

Kansas City, Missouri, 64132, United States

Location

Mercy Research Oncology

St Louis, Missouri, 63141, United States

Location

CHI Health St. Francis

Grand Island, Nebraska, 68803, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

Queens Hospital Cancer Center

New York, New York, 11432, United States

Location

OHSU Knight Cancer Institute Hematology Oncology

Portland, Oregon, 97210, United States

Location

Magee Women's Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University Medical Center

Tennessee City, Tennessee, 37204, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

West Virginia University Hospital

Morgantown, West Virginia, 26506, United States

Location

Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan

San Juan, Buenos Aires, J5402DIL, Argentina

Location

Centro de Investigación Clínica - Clínica Viedma

Viedma, Río Negro Province, 8500, Argentina

Location

Sanatorio Parque de Rosario

Rosario, Santa Fe Province, S2000, Argentina

Location

CAIPO Centro para la atención integral del paciente oncológico

San Miguel de Tucumán, 4000, Argentina

Location

Grand Hopital de Charleroi asbl

Charleroi, Hainaut, 6000, Belgium

Location

UZ Antwerpen

Antwerp, 2650, Belgium

Location

CHIREC Centre Hospitalier Interregional Edith Cavell

Brussels, 1160, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

CHU de Liège

Liège, 4000, Belgium

Location

Centro de Oncologia Da Bahia

Bahia, 41820-021, Brazil

Location

Universidade de Caxias do Sul (IPCEM-UCS)

Caxias do Sul, 95070-560, Brazil

Location

Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner

Curitiba, 81520-060, Brazil

Location

Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)

Porto Alegre, 90610-000, Brazil

Location

INCA Instituto Nacional De Cancer

Rio de Janeiro, 20560-120, Brazil

Location

Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto

São José do Rio Preto, 15090-000, Brazil

Location

Clinica de Pesquisas e Centro de Estudos Oncologia Ginecologica e Mamaria Ltda

São Paulo, 01317-001, Brazil

Location

Multiscan s.r.o - Onkologická ambulance

Hořovice, 28831, Czechia

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, 50005, Czechia

Location

Fakultni nemocnice v Motole

Prague, 15000, Czechia

Location

Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

Lyon, 69008, France

Location

Institut de Cancérologie de l'Ouest

Saint-Herblain, 44800, France

Location

EDOG - Institut Claudius Regaud - PPDS

Toulouse, 31100, France

Location

Ospedale San Raffaele S.r.l. - PPDS

Milan, Lombardy, 20132, Italy

Location

ASST di Monza - Azienda Ospedaliera San Gerardo

Monza, Milano, 20900, Italy

Location

Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

Bologna, 40138, Italy

Location

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

Catania, 95123, Italy

Location

Azienda Ospedaliera Universitaria - Università degli studi della Campania "Luigi Vanvitelli"

Napoli, 80131, Italy

Location

LLC Evimed

Chelyabinsk, 454048, Russia

Location

Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy

Krasnoyarsk, 191024, Russia

Location

Medical Center Tonus

Nizhny Novgorod, 603089, Russia

Location

Budgetary Healthcare Institution of the Omsk region "Clinical Oncology Dispensary"

Omsk, 644013, Russia

Location

Evromedservis LCC

Pushkin, 196603, Russia

Location

Mordovia State University

Saransk, 430000, Russia

Location

Research Oncology Institute of Tomsk Scientific Center

Tomsk, 634009, Russia

Location

Volgograd Regional Clinical Oncology Dispensary

Volgograd, 400138, Russia

Location

National Cancer Center

Goyang-si, 10408, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Ulsan University Hospital

Ulsan, 44033, South Korea

Location

Hospital Universitario Virgen Macarena

Seville, Andalusia, 41009, Spain

Location

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

ICO l'Hospitalet - Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Hospital Quironsalud Barcelona

Barcelona, Catalonia, 8023, Spain

Location

Hospital Universitari Arnau de Vilanova

Lleida, Catalonia, 25198, Spain

Location

Hospital Universitario A Coruña

A Coruña, 15006, Spain

Location

Hospital Universitario de Badajoz

Badajoz, 06006, Spain

Location

Hospital Universitario Vall D'Hebrón

Barcelona, 08035, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Ruber Internacional

Madrid, 28034, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Chi Mei Medical Center, Liouying

Tainan, 736, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, 11259, Taiwan

Location

Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS

Dnipro, 49102, Ukraine

Location

LLC Medical Center Family Medicine Clinic

Dnipro, 49600, Ukraine

Location

Municipal Institution SubCarpathian Clinical Oncological Centre

Ivano-Frankivsk, 76018, Ukraine

Location

CNCE of Lviv Regional Council Lviv Oncological Regional Therapeutical and Diagnostic Centre

Lviv, 79031, Ukraine

Location

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

Barts Cancer Institute

London, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

eribulin; balixafortide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

The trial was halted early due to failure to meet the primary endpoint.

Results Point of Contact

• Title: Christian Zwingelstein
• Organization: Spexis AG

info@spexisbio.com

+41 61 567 16 00

Study Officials

• François Ringeisen, MD

  Polyphor Ltd.

  STUDY DIRECTOR

• Peter A Kaufman, MD

  UVM medical center; USA

  PRINCIPAL INVESTIGATOR

• Javier Cortes, MD

  IOB and VHIO; Spain

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 24, 2018
• Study Start: May 30, 2019
• Primary Completion: October 19, 2021
• Study Completion: October 19, 2021
• Last Updated: November 1, 2023
• Results First Posted: November 1, 2023

Record last verified: 2023-10

Locations

BR (7); RU (8); FR (3); ES (12); AR (4); CZ (3); US (28); IT (5); KR (4); TW (3); BE (5); UA (4); GB (2)