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

• Status: Active, not recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Polyphor Ltd.

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