Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Not reveal any significant difference between the 2 treatment arms
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| First Line Metastatic Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Exemestane | Drug | Exemestane | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- paclitaxel-bevacizumab
- description
- Paclitaxel, 80mg/m² at d1, d8, d15 bevacizumab, 10 mg/kg at d1, d15
- interventionNames
- Drug: Paclitaxel
- Drug: Bevacizumab
- type
- EXPERIMENTAL
- label
- exemestane-bevacizumab
- description
- exemestane, 25 mg daily dose bevacizumab, 15mg/kg every 3 weeks
- interventionNames
- Drug: Bevacizumab
- Drug: Exemestane
Primary outcomes (1)
- measure
- Primary free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDTredan 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. PMID 26916095