Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer
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.
Timeline
- Start
- 2019-05-30
- Primary completion
- 2021-10-19
- Completion
- 2021-10-19
Outcome
Missed primary endpoint
Stopped: “The study was halted early due to failure to meet the primary endpoint.”
registry analysis (superiority test); Balixafortide + Eribulin vs Eribulin Monotherapy; p = 0.4450; Hazard Ratio (HR) 1.10 (96% CI 0.85 to 1.41); t-test, 2 sided NCT03786094 ↗
registry analysis (superiority test); Balixafortide + Eribulin vs Eribulin Monotherapy; p = 0.6158; Hazard Ratio (HR) 1.07 (96% CI 0.81 to 1.41); t-test, 2 sided NCT03786094 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Balixafortide | Peptide | — | Intravenous |
| Subject | Eribulin | Small molecule | — | — |