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

September 5, 2023 updated by: ARCAGY/ GINECO GROUP

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

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69000
        • BACHELOT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Drug: Paclitaxel
IV, 80mg/m² at d1, d8, d15
Drug: Bevacizumab
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
Drug: Bevacizumab
IV, 10 mg/kg at d1, d15 or IV, 15 mg/kg every 3 weeks
Drug: Exemestane
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

This is where you will find people and organizations involved with this study.

Sponsor

ARCAGY/ GINECO GROUP

Investigators

  • Principal Investigator: Thomas BACHELOT, Md, GINECO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

February 23, 2011

First Submitted That Met QC Criteria

February 24, 2011

First Posted (Estimated)

February 25, 2011

Study Record Updates

Last Update Posted (Estimated)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Arobase (GINECO-BR107)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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