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

Trial Status: Active

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.

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

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

California

Palo Alto
Stanford Cancer Institute Palo Alto
Status: ACTIVE
San Francisco
UCSF Medical Center-Mount Zion
Status: ACTIVE
Contact: Helen Diller Family Comprehensive Cancer Center
Phone: 877-827-3222

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE

Oregon

Portland
OHSU Knight Cancer Institute
Status: ACTIVE

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: APPROVED
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE

South Carolina

Charleston
Medical University of South Carolina
Status: IN_REVIEW
Contact: Sara Barnato Giordano
Phone: 843-792-4271

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Polyphor Limited

  • Primary ID POL6326-009
  • Secondary IDs NCI-2019-00894
  • Clinicaltrials.gov ID NCT03786094