Clinical trial · Interventional
First Line Metastatic Breast Cancer Treatment (ESMERALDA)
A PHASE II TRIAL EVALUATING THE COMBINATION OF ERIBULIN (HALAVEN®) + BEVACIZUMAB (AVASTIN®) AS A FIRST LINE TREATMENT IN PATIENTS WITH METASTATIC HER2- BREAST CANCER
NCT01941407CI-TRIAL-00021410ESMERALDAcompletedPhase 2ClinicalTrials.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 efficacy of eribulin is now well known in metastatic breast cancer. Furthermore, a phase III combine study ( chemo + bev)in metastatic first line shown a gain in PFS with no extra toxicities. It could be interesting to explore the combination of bev + eribulin in first line metastatic breast cancer.
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eribulin | Drug | Eribulin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Association eribulin and bevacizumab
- description
- Drug: eribulin 1,23mg/m²; d1 and d8 in IV, all 3 weeks until 6 cycles or progression Drug: bevacizumab 15m/kg ; d1 in IV, all 3 weeks until 6 cycles or progression or toxicity
- interventionNames
- Drug: Eribulin
Primary outcomes (1)
- measure
- Number of patient with non progressive disease
- timeFrame
- 12 months
- description
- The principal endpoint is to determine the disease control rate (or rate of non-progression) at one year in patients with metastatic breast cancer treated in the first line setting by a combination of eribulin/bevacizumab. In this open-label trial, the sample size is calculated based on Simon's two-stage design, used to test whether the disease control rate at one year will be at least 50%, a clinically promising rate, versus a rate of 33%, a rate that is not clinically promising. Considering a type I risk (alpha) error of 5%, with 54 patients, this study has an 80% power to detect a disease control rate at one year of 50%.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 ans * Patient with metastatic mammary adenocarcinoma * Hormone receptors ER and PR positive or negative for HER 2 negative Exclusion Criteria: * Prior chemotherapy for metastatic disease * Previous treatment with eribulin or bevacizumab * Presence of symptomatic brain metastases or meningeal
References
Publications (0)
Data not yet available
No reference posted for this study.