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

Study Overview
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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.

Official Title
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Phase III Randomized Multicenter Trial Comparing Continued Maintenance Therapy With the Bevacizumab + Taxane Versus Bevacizumab + Substituting Exemestane in Patients With Metastatic Breast Cancer or Locally Advanced With Estrogen Receptor Positive and Having at Least a Stable Disease After 16 to 18 Weeks of Treatment With Bevacizumab + Taxane.

Conditions
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First Line Metastatic Breast Cancer

Intervention / Treatment
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* Drug: Paclitaxel
* Drug: Bevacizumab
* Drug: Exemestane


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: paclitaxel-bevacizumab<br>Paclitaxel, 80mg/m² at d1, d8, d15 bevacizumab, 10 mg/kg at d1, d15 | Drug: Paclitaxel<br>* IV, 80mg/m² at d1, d8, d15<br>Drug: Bevacizumab<br>* IV, 10 mg/kg at d1, d15 or IV, 15 mg/kg every 3 weeks<br>|
| Experimental: exemestane-bevacizumab<br>exemestane, 25 mg daily dose bevacizumab, 15mg/kg every 3 weeks | Drug: Bevacizumab<br>* IV, 10 mg/kg at d1, d15 or IV, 15 mg/kg every 3 weeks<br>Drug: Exemestane<br>* daily 25 mg (1 pill) oral intake<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary free survival |  | 24 months for recruitment and 18 months for follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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First line metastatic breast cancer, Positive estrogen receptors, Negative HER2 receptors, At least stable disease after 4 months of paclitaxel-bevcizumab induction chemotheray