Study in HER2(-), Locally Recurrent or Metastatic Breast Cancer

July 16, 2019

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 Information

    Trial Contact: Jobson, Gillian S; Morales, Leticia; Jarquin-Castillo, Katherine

  • IRB No: 19.035.03

    Protocol Abbrev: POL6326-009

    Principal Investigator: Regan Derek Rostorfer, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: POL6326-009

    Treatment: Balixafortide + eribulin treatment or Eribulin treatment only

    Therapies Involved: Chemotherapy; Oncology: 3rd line/Refractory

    ClinicalTrials.gov ID: NCT03786094

  • Objective

    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

  • Key Eligibility

    Key Inclusion Criteria:
    •   18 Years and older
    •   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