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

Spexis

Status and phase: Terminated; Phase 3

Conditions: Locally Recurrent Breast Cancer; Metastatic Breast Cancer

Treatments: Drug: Eribulin; Drug: Balixafortide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03786094

POL6326-009

Details and patient eligibility

About

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.

Enrollment: 432 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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432 participants in 2 patient groups

Eribulin

Active Comparator group

Treatment:

Drug: Eribulin

Balixafortide + Eribulin

Experimental group

Treatment:

Drug: Balixafortide

Drug: Eribulin