Vanderbilt Clinical Trials

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

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.

Conditions

Metastatic Breast Cancer
Locally Recurrent Breast Cancer

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator Eribulin		Drug: Eribulin Eribulin alone Other names: Eribulin Injection [Halaven] Drug: Balixafortide Balixafortide + Eribulin Other names: POL6326
Experimental Balixafortide + Eribulin		Drug: Eribulin Eribulin alone Other names: Eribulin Injection [Halaven] Drug: Balixafortide Balixafortide + Eribulin Other names: POL6326

More Details

Status: Terminated
Sponsor: Spexis AG

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.