- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01303679
1st Line Treatment of Bevacizumab-Taxane vs Bevacizumab-Exemestane in Metastatic Breast Cancer
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Lyon, France, 69000
- BACHELOT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: paclitaxel-bevacizumab
Paclitaxel, 80mg/m² at d1, d8, d15 bevacizumab, 10 mg/kg at d1, d15
|
IV, 80mg/m² at d1, d8, d15
IV, 10 mg/kg at d1, d15 or IV, 15 mg/kg every 3 weeks
|
Experimental: exemestane-bevacizumab
exemestane, 25 mg daily dose bevacizumab, 15mg/kg every 3 weeks
|
IV, 10 mg/kg at d1, d15 or IV, 15 mg/kg every 3 weeks
daily 25 mg (1 pill) oral intake
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Primary free survival
Time Frame: 24 months for recruitment and 18 months for follow up
|
24 months for recruitment and 18 months for follow up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas BACHELOT, Md, GINECO
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Paclitaxel
- Bevacizumab
- Exemestane
Other Study ID Numbers
- Arobase (GINECO-BR107)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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