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

NCT01303679 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2023-09-06

No results posted yet for this study

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.

Conditions

  • First Line Metastatic Breast Cancer

Interventions

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

DRUG

Exemestane

daily 25 mg (1 pill) oral intake

Sponsors & Collaborators

  • ARCAGY/ GINECO GROUP

    lead OTHER

Principal Investigators

  • Thomas BACHELOT, Md · GINECO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2014-06-30
Completion
2018-05-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01303679 on ClinicalTrials.gov