First Line Metastatic Breast Cancer Treatment (ESMERALDA)

ARCAGY/ GINECO GROUP

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: Eribulin

Study type: Interventional

Funder types: Other

Identifiers

NCT01941407

GINECO-BR110

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

Association eribulin and bevacizumab

Experimental group

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

Treatment:

Drug: Eribulin