Fulvestrant (Faslodex) + Anastrozole (Arimidex) vs Anastrozole

Summary

Postmenopausal women with hormone receptor positive and negative Her2 tumours. Before randomization, the patients will be stratified according to the center, positive nodes (0 vs. 1-3 vs. ≥4), previous chemotherapy (yes vs no) and hormonal receptors status.

Timeline

Start

2007-11

Primary completion

2016-07

Completion

2016-07

Outcome

Missed primary endpoint

Stopped (Business): “Unjustified decision of company that funded the trial.”

paper The Hazard Ratio for DFS (combination vs. anastrozole) was 0.84 (95% CI 0.58-1.22; p = 0.352). PMID 31152327 ↗

paper The GEICAM/2006-10 study did not show a statistically significant increase in DFS by adding adjuvant F to A PMID 31152327 ↗

Publications

• Results Ruiz-Borrego M, Guerrero-Zotano A, Bermejo B, Ramos M, Cruz J, Baena-Canada JM, Cirauqui B, Rodriguez-Lescure A, Alba E, Martinez-Janez N, Munoz M, Antolin S, Alvarez I, Del Barco S, Sevillano E, Chacon JI, Anton A, Escudero MJ, Ruiz V, Carrasco E, Martin M; GEICAM. Phase III evaluating the addition of fulvestrant (F) to anastrozole (A) as adjuvant therapy in postmenopausal women with hormone receptor-positive HER2-negative (HR+/HER2-) early breast cancer (EBC): results from the GEICAM/2006-10 study. Breast Cancer Res Treat. 2019 Aug;177(1):115-125. doi: 10.1007/s10549-019-05296-8. Epub 2019 May 31.
• Servitja S, Carrasco E, Andres R, Rodriguez-Lescure A, Martin M, Ruiz-Borrego M, Guerrero A, Bermejo B, Anton A, Munoz M, Margeli M, Alvarez I, Fernandez LA, Ponce J, Cruz J, Martinez P, Lopez-Tarruella S, Amenedo M, Blasco A, Polonio O, Gil-Gil M. Outcomes of Hormone receptor-positive/HER2-negative early breast cancer patients by risk of recurrence groups focusing on the intermediate-risk group: Retrospective analysis from GEICAM studies. Breast Cancer Res. 2026 May 25. doi: 10.1186/s13058-026-02300-0. Online ahead of print.
• Martin M, Carrasco E, Rodriguez-Lescure A, Andres R, Servitja S, Anton A, Ruiz-Borrego M, Bermejo B, Guerrero A, Ramos M, Santaballa A, Munoz M, Cruz J, Lopez-Tarruella S, Chacon JI, Alvarez I, Martinez P, Miralles JJ, Polonio O, Jara C, Aguiar-Bujanda D. Long-term outcomes of high-risk HR-positive and HER2-negative early breast cancer patients from GEICAM adjuvant studies and El Alamo IV registry. Breast Cancer Res Treat. 2023 Sep;201(2):151-159. doi: 10.1007/s10549-023-07002-1. Epub 2023 Jun 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Anastrozole	Other / unclassified	1 mg	Oral
Subject	Fulvestrant	Small molecule	250 mg	Intramuscular

Indications