Clinical trial · Observational
Eribulin Use for the Treatment of Advanced Breast Cancer: A Prospective Observational Registry
Eribulin (HALAVEN) Use for the Treatment of Advanced Breast Cancer: A Prospective Observational Registry
NCT02443428CI-TRIAL-00021766completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this prospective observational registry is to monitor safety of eribulin in routine clinical practice. Additionally, this study will also assess the effectiveness of eribulin in real-life settings.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Eribulin Mesilate
- description
- Participants will be treated in accordance with normal clinical practice. The recommend dose of eribulin is 1.23 mg/m2 administered intravenously on days 1 and 8 of every 21-day cycle. Treatment with eribulin is continued until disease progression, onset of unacceptable drug toxicities, or participant/physician's request to discontinue.
Primary outcomes (1)
- measure
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)
- timeFrame
- From date of first administration of study drug up to 30 days after last administration of study drug or until approximately 2 years
- description
- Safety assessment will consist of monitoring of all AEs, including SAEs at every visit. All participants will be evaluable for safety from the time of their first treatment with eribulin.
Secondary outcomes (8)
- measure
- Tumour response
- timeFrame
- From date of enrollment, Day 1 and Day 8 of every 21 day cycle or up to approximately 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria The participants have to meet all of the following criteria to be eligible to enter into the prospective registry: 1. Participants older than 18 years of age 2. Willing and able to provide informed consent 3. Diagnosis of locally advanced or metastatic breast cancer 4. Progression after up to two previous chemotherapy regimens for advanced disease. Prior therapy should have included an anthracycline and a taxanes in either the adjuvant or advanced setting unless not suitable 5. Adequate bone marrow, liver, and renal function 6. Life expectancy greater than 12 weeks Exclusion Criteria Participants meeting the following criteria will not be permitted to enter the study: 1. Prior treatment with eribulin 2. Participants who have received more than two prior chemotherapeutic regimens for advanced disease
References
Publications (0)
Data not yet available
No reference posted for this study.