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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01941407

Acronym

ESMERALDA

Enrollment

Registered

2013-09-13

Start date

2013-11-30

Completion date

2016-03-31

Last updated

2016-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer

Brief summary

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.

Interventions

DRUGEribulin

Eribulin: 1,23mg/m² d1, d8, IV Bevacizumab: 15mg/kg d1, IV

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of patient with non progressive disease	12 months	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

Measure	Time frame
Toxicity based on the CTCAE v4.03 criteria	12 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026