1st Line Treatment of Bevacizumab-Taxane vs Bevacizumab-Exemestane in Metastatic Breast Cancer

ARCAGY/ GINECO GROUP

Status and phase: Terminated; Phase 3

Conditions: First Line Metastatic Breast Cancer

Treatments: Drug: Paclitaxel; Drug: Bevacizumab; Drug: Exemestane

Study type: Interventional

Funder types: Other

Identifiers

NCT01303679

Arobase (GINECO-BR107)

Details and patient eligibility

About

In first-line metastatic breast cancer, the bevacizumab-taxane to progression or toxicity, is currently the standard treatment. In patients expressing hormone receptors, it was shown that hormone therapy administered in maintenance after induction chemotherapy, could have a benefit regarding the progression-free survival. The investigators make the hypothesis that there would be interest to discontinue treatment with taxane after 4 months, and to begin hormone therapy while continuing maintenance bevacizumab.

Exemestane was chosen because it has been shown potentially active in patients who progressed after letrozole, anastrozole or tamoxifen.

Enrollment: 117 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 ans.
• Metastatic breast cancer or locally advanced
• RE+, HER2-
• Patient receiving paclitaxel-bevacizumab first line chemotherapy

Exclusion criteria

• Previous treatment by exemestane (both in adjuvant or metastatic treatment).
• 1st line of chemotherapy different thaan paclitaxel-bevacizumab.
• Treatment by paclitaxel-bevacizumab > 18 weeks.
• HER2 positifs et/ou récepteurs aux oestrogènes négatifs.
• Previous thrombosis event within the 6 months before inclusion .
• Previous significant surgery within the 28 days before treatment start
• Previuous coagulopathy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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117 participants in 2 patient groups

paclitaxel-bevacizumab

Active Comparator group

Description:

Paclitaxel, 80mg/m² at d1, d8, d15 bevacizumab, 10 mg/kg at d1, d15

Treatment:

Drug: Paclitaxel

Drug: Bevacizumab

exemestane-bevacizumab

Experimental group

Description:

exemestane, 25 mg daily dose bevacizumab, 15mg/kg every 3 weeks

Treatment:

Drug: Exemestane

Drug: Bevacizumab