Trials / Terminated
TerminatedNCT03786094
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 432 (actual)
- Sponsor
- Spexis AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Eribulin | Eribulin alone |
| DRUG | Balixafortide | Balixafortide + Eribulin |
Timeline
- Start date
- 2019-05-30
- Primary completion
- 2021-10-19
- Completion
- 2021-10-19
- First posted
- 2018-12-24
- Last updated
- 2023-11-01
- Results posted
- 2023-11-01
Locations
88 sites across 13 countries: United States, Argentina, Belgium, Brazil, Czechia, France, Italy, Russia, South Korea, Spain, Taiwan, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03786094. Inclusion in this directory is not an endorsement.