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

Primary Purpose

First Line Metastatic Breast Cancer

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Paclitaxel
Bevacizumab
Exemestane
Sponsored by
ARCAGY/ GINECO GROUP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for First Line Metastatic Breast Cancer focused on measuring First line metastatic breast cancer, Positive estrogen receptors, Negative HER2 receptors, At least stable disease after 4 months of paclitaxel-bevcizumab induction chemotheray

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • BACHELOT

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

paclitaxel-bevacizumab

exemestane-bevacizumab

Arm Description

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

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

Outcomes

Primary Outcome Measures

Primary free survival

Secondary Outcome Measures

Full Information

First Posted
February 23, 2011
Last Updated
September 5, 2023
Sponsor
ARCAGY/ GINECO GROUP
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1. Study Identification

Unique Protocol Identification Number
NCT01303679
Brief Title
1st Line Treatment of Bevacizumab-Taxane vs Bevacizumab-Exemestane in Metastatic Breast Cancer
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Not reveal any significant difference between the 2 treatment arms
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ARCAGY/ GINECO GROUP

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
First Line Metastatic Breast Cancer
Keywords
First line metastatic breast cancer, Positive estrogen receptors, Negative HER2 receptors, At least stable disease after 4 months of paclitaxel-bevcizumab induction chemotheray

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
paclitaxel-bevacizumab
Arm Type
Active Comparator
Arm Description
Paclitaxel, 80mg/m² at d1, d8, d15 bevacizumab, 10 mg/kg at d1, d15
Arm Title
exemestane-bevacizumab
Arm Type
Experimental
Arm Description
exemestane, 25 mg daily dose bevacizumab, 15mg/kg every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
IV, 80mg/m² at d1, d8, d15
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
IV, 10 mg/kg at d1, d15 or IV, 15 mg/kg every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Exemestane
Intervention Description
daily 25 mg (1 pill) oral intake
Primary Outcome Measure Information:
Title
Primary free survival
Time Frame
24 months for recruitment and 18 months for follow up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas BACHELOT, Md
Organizational Affiliation
GINECO
Official's Role
Principal Investigator
Facility Information:
Facility Name
BACHELOT
City
Lyon
ZIP/Postal Code
69000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26916095
Citation
Tredan O, Follana P, Moullet I, Cropet C, Trager-Maury S, Dauba J, Lavau-Denes S, Dieras V, Beal-Ardisson D, Gouttebel M, Orfeuvre H, Stefani L, Jouannaud C, Burki F, Petit T, Guardiola E, Becuwe C, Blot E, Pujade-Lauraine E, Bachelot T. A phase III trial of exemestane plus bevacizumab maintenance therapy in patients with metastatic breast cancer after first-line taxane and bevacizumab: a GINECO group study. Ann Oncol. 2016 Jun;27(6):1020-1029. doi: 10.1093/annonc/mdw077. Epub 2016 Feb 24.
Results Reference
derived

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

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