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

First Line Metastatic Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01303679
• Other study ID #: Arobase (GINECO-BR107)
• Status: Terminated
• Phase: Phase 3
• Start date: June 2010
• Est. completion date: May 2018

Study information

• Verified date: September 2023
• Source: ARCAGY/ GINECO GROUP
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 117
• Est. completion date: May 2018
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• First Line Metastatic Breast Cancer

Intervention

Drug:
• Paclitaxel
IV, 80mg/m² at d1, d8, d15
• Bevacizumab
IV, 10 mg/kg at d1, d15 or IV, 15 mg/kg every 3 weeks
• Exemestane
daily 25 mg (1 pill) oral intake

Locations

Country	Name	City	State
France	BACHELOT	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
ARCAGY/ GINECO GROUP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary free survival		24 months for recruitment and 18 months for follow up