drugset / Trial / NCT00545077
Bevacizumab + Endocrine Treatment vs Endocrine Treatment as First Line in Postmenopausal Women
Phase 3
Completed
380 enrolled
Spanish Breast Cancer Research Group
GBG Forschungs GmbH · collabHoffmann-La Roche · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Locally advanced or metastatic breast cancer in postmenopausal women with negative Human Epidermal Growth Factor Receptor 2 (HER2), who are candidates for hormone treatment and who have not received previous chemotherapy or hormonotherapy for the metastatic disease.
Timeline
- Start
- 2007-11-06
- Primary completion
- 2013-12
- Completion
- 2014-07-24
Outcome
Missed primary endpoint
paper The addition of bevacizumab to ET in first-line treatment failed to produce a statistically significant increase in PFS or OS. PMID 25691671 ↗
paper Median PFS was 14.4 months in the ET arm and 19.3 months in the ET-B arm (hazard ratio, 0.83; 95% CI, 0.65 to 1.06; P = .126). PMID 25691671 ↗
Publications
- Results Martin M, Loibl S, von Minckwitz G, Morales S, Martinez N, Guerrero A, Anton A, Aktas B, Schoenegg W, Munoz M, Garcia-Saenz JA, Gil M, Ramos M, Margeli M, Carrasco E, Liedtke C, Wachsmann G, Mehta K, De la Haba-Rodriguez JR. Phase III trial evaluating the addition of bevacizumab to endocrine therapy as first-line treatment for advanced breast cancer: the letrozole/fulvestrant and avastin (LEA) study. J Clin Oncol. 2015 Mar 20;33(9):1045-52. doi: 10.1200/JCO.2014.57.2388. Epub 2015 Feb 17.
- Results Martin M, Loibl S, Hyslop T, De la Haba-Rodriguez J, Aktas B, Cirrincione CT, Mehta K, Barry WT, Morales S, Carey LA, Garcia-Saenz JA, Partridge A, Martinez-Janez N, Hahn O, Winer E, Guerrero-Zotano A, Hudis C, Casas M, Rodriguez-Martin C, Furlanetto J, Carrasco E, Dickler MN; GEICAM Spanish Breast Cancer Group; GBG (German Breast Group); Alliance for Clinical Trials in Oncology (Alliance). Evaluating the addition of bevacizumab to endocrine therapy as first-line treatment for hormone receptor-positive metastatic breast cancer: a pooled analysis from the LEA (GEICAM/2006-11_GBG51) and CALGB 40503 (Alliance) trials. Eur J Cancer. 2019 Aug;117:91-98. doi: 10.1016/j.ejca.2019.06.002. Epub 2019 Jul 2.
- Results Polley MC, Dickler MN, Sinnwell J, Tenner K, de la Haba J, Loibl S, Goetz MP, Bergh J, Roberston J, Couch F, Ellis MJ, Martin M. A clinical calculator to predict disease outcomes in women with hormone receptor-positive advanced breast cancer treated with first-line endocrine therapy. Breast Cancer Res Treat. 2021 Aug;189(1):15-23. doi: 10.1007/s10549-021-06319-z. Epub 2021 Jul 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | Fulvestrant | Small molecule | — | — |
| Subject | Letrozole | Other / unclassified | — | — |