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.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01303679

Enrollment

117

Registered

2011-02-25

Start date

2010-06-30

Completion date

2018-05-31

Last updated

2023-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGBevacizumab

IV, 10 mg/kg at d1, d15 or IV, 15 mg/kg every 3 weeks

DRUGExemestane

daily 25 mg (1 pill) oral intake

DRUGPaclitaxel

IV, 80mg/m² at d1, d8, d15

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Primary free survival	24 months for recruitment and 18 months for follow up

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026