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Completed

NCT Number: NCT01941407

First Line Metastatic Breast Cancer Treatment (ESMERALDA)

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.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Centre Paul Papin, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eribulin

Drug

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

Other names: Drug: Bevacizumab

Primary outcomes

  1. Number of patient with non progressive disease

    Time frame: 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 outcomes

  1. Toxicity based on the CTCAE v4.03 criteria

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

ARCAGY/ GINECO GROUP

Other

Registry information

Official study title

A PHASE II TRIAL EVALUATING THE COMBINATION OF ERIBULIN (HALAVEN®) + BEVACIZUMAB (AVASTIN®) AS A FIRST LINE TREATMENT IN PATIENTS WITH METASTATIC HER2- BREAST CANCER

Acronym: ESMERALDA

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
Sep 13, 2013
Registry last updated
Mar 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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