Trials / Withdrawn
WithdrawnNCT03637868
Eribulin in Brain Metastases From HER2-negative Breast Cancer
A Phase II Study of Eribulin in Brain Metastases From HER2-negative Breast Cancer Pre-treated With Anthracyclines and Taxanes
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Institut Paoli-Calmettes · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the efficacy of eribulin for treatment of HER2-negative breast cancer brain metastases (BCBM)
Detailed description
This study will explore eribulin in three specific cohorts of patients with HER2-negative metastatic breast cancer harboring BCBM, pretreated with anthracyclines and taxanes: * Cohort A = Newly diagnosed, untreated BCBM, not candidate to initial surgery or stereotactic radiosurgery (SRS) and with pauci-symptomatic disease not requiring immediate whole-brain radiation therapy (WBRT) * Cohort B = BCBM pretreated with SRS and/or surgery alone, without WBRT, and not requiring immediate WBRT * Cohort C = BCBM pretreated with WBRT
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Eribulin | Patients will receive eribulin 1.4 mg/m² administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. |
Timeline
- Start date
- 2019-02-26
- Primary completion
- 2020-04-14
- Completion
- 2020-04-14
- First posted
- 2018-08-20
- Last updated
- 2020-05-06
Locations
7 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03637868. Inclusion in this directory is not an endorsement.