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

Status: Active

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.

Eligibility Criteria

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

Locations & Contacts

California

San Francisco
UCSF Medical Center-Mount Zion
Status: Approved
Contact: Helen Diller Family Comprehensive Cancer Center
Phone: 877-827-3222
Email: cancertrials@ucsf.edu

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: Approved
Name Not Available
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available

South Carolina

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

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Polyphor Limited

Trial IDs

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