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

NCT03786094 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2023-11-01

Study results available
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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

Interventions

DRUG

Eribulin

Eribulin alone

DRUG

Balixafortide

Balixafortide + Eribulin

Sponsors & Collaborators

  • Spexis AG

    lead INDUSTRY

Principal Investigators

  • François Ringeisen, MD · Polyphor Ltd.

  • Peter A Kaufman, MD · UVM medical center; USA

  • Javier Cortes, MD · IOB and VHIO; Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-30
Primary Completion
2021-10-19
Completion
2021-10-19
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Czechia
  • France
  • Italy
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03786094 on ClinicalTrials.gov