Clinical Trials /

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

NCT03786094

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: POL6326-009
  • NCT ID: NCT03786094

Conditions

  • Metastatic Breast Cancer
  • Locally Recurrent Breast Cancer

Interventions

DrugSynonymsArms
EribulinEribulin Injection [Halaven]Eribulin
BalixafortidePOL6326Balixafortide + eribulin

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
EribulinActive Comparator
  • Eribulin
Balixafortide + eribulinExperimental
  • Eribulin
  • Balixafortide

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival as assessed by Independent Review Committee
Time Frame:12 months after last patient randomized
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Polyphor Ltd.

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