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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2018-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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First Line Metastatic Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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paclitaxel-bevacizumab

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

Group Type ACTIVE_COMPARATOR

Paclitaxel

Intervention Type DRUG

IV, 80mg/m² at d1, d8, d15

Bevacizumab

Intervention Type DRUG

IV, 10 mg/kg at d1, d15 or IV, 15 mg/kg every 3 weeks

exemestane-bevacizumab

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

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

IV, 10 mg/kg at d1, d15 or IV, 15 mg/kg every 3 weeks

Exemestane

Intervention Type DRUG

daily 25 mg (1 pill) oral intake

Interventions

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Paclitaxel

IV, 80mg/m² at d1, d8, d15

Intervention Type DRUG

Bevacizumab

IV, 10 mg/kg at d1, d15 or IV, 15 mg/kg every 3 weeks

Intervention Type DRUG

Exemestane

daily 25 mg (1 pill) oral intake

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No