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

Phase 3

Terminated

• Conditions: First Line Metastatic Breast Cancer
• Interventions: Drug: Paclitaxel; Drug: Bevacizumab; Drug: Exemestane

• Registration Number: NCT01303679
• Lead Sponsor: ARCAGY/ GINECO GROUP

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2011-02-23
• Study First Submitted QC: 2011-02-24
• Study First Posted: 2011-02-25
• Primary Completion: 2014-06
• Study Completion: 2018-05
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 117

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
paclitaxel-bevacizumab	Paclitaxel	Paclitaxel, 80mg/m² at d1, d8, d15 bevacizumab, 10 mg/kg at d1, d15
paclitaxel-bevacizumab	Bevacizumab	Paclitaxel, 80mg/m² at d1, d8, d15 bevacizumab, 10 mg/kg at d1, d15
exemestane-bevacizumab	Bevacizumab	exemestane, 25 mg daily dose bevacizumab, 15mg/kg every 3 weeks
exemestane-bevacizumab	Exemestane	exemestane, 25 mg daily dose bevacizumab, 15mg/kg every 3 weeks

Primary Outcome Measures

Name	Time	Method
Primary free survival	24 months for recruitment and 18 months for follow up

Trial Locations

Locations (1)

BACHELOT; 🇫🇷 Lyon, France