Clinical trial · Interventional
Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer
An International, Phase 3, Multicenter, Randomized, Open- Label Trial Comparing Balixafortide in Combination With Eribulin Versus Eribulin Alone in Patients With HER2 Negative, Locally Recurrent or Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was halted early due to failure to meet the primary endpoint.
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Recurrent Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Balixafortide | Drug | — | UNRESOLVED |
| Eribulin | Drug | Eribulin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Eribulin
- interventionNames
- Drug: Eribulin
- type
- EXPERIMENTAL
- label
- Balixafortide + Eribulin
- interventionNames
- Drug: Eribulin
- Drug: Balixafortide
Primary outcomes (2)
- measure
- Progression Free Survival (2nd Line+ Population)
- timeFrame
- Patients received treatment until PD by RECIST v1.1 criteria was met or until one of the treatment discontinuation or study withdrawal criteria was met.
- description
- To evaluate the efficacy of balixafortide + eribulin versus eribulin monotherapy on the primary endpoint of progression free survival (PFS). PFS, as assessed by the Independent Review Committee, defined as the time from the date of randomization to the earliest evidence of documented progressive disease or death from any cause. Patients who were alive without postbaseline assessments or without documented progressive disease, lost to follow-up, withdrew consent, started an anticancer therapy prior to observing a progressive disease or with an event documented after 2 or more missing tumor assessments were censored. PFS was evaluated according to RECIST v1.1 guidelines for complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available