RT Journal Article T1 Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial A1 Robertson, John F. R. A1 Bondarenko, Igor M. A1 Trishkina, Ekaterina A1 Dvorkin, Mikhail A1 Panasci, Lawrence A1 Manikhas, Alexey A1 Shparyk, Yaroslav A1 Cardona-Huerta, Servando A1 Cheung, Kwok-Leung A1 Philco-Salas, Manuel Jesus A1 Ruiz-Borrego, Manuel A1 Shao, Zhimin A1 Noguchi, Shinzaburo A1 Rowbottom, Jacqui A1 Stuart, Mary A1 Grinsted, Lynda M. A1 Fazal, Mehdi A1 Ellis, Matthew J. K1 First-line therapy K1 Postmenopausal women K1 Endocrine-therapy K1 1st-line therapy K1 Tamoxifen K1 Letrozole K1 Superior K1 Survival K1 Efficacy AB Background Aromatase inhibitors are a standard of care for hormone receptor-positive locally advanced or metastatic breast cancer. We investigated whether the selective oestrogen receptor degrader fulvestrant could improve progression-free survival compared with anastrozole in postmenopausal patients who had not received previous endocrine therapy.Methods In this phase 3, randomised, double-blind trial, we recruited eligible patients with histologically confi rmed oestrogen receptor-positive or progesterone receptor-positive, or both, locally advanced or metastatic breast cancer from 113 academic hospitals and community centres in 20 countries. Eligible patients were endocrine therapy-naive, with WHO performance status 0-2, and at least one measurable or non-measurable lesion. Patients were randomly assigned (1: 1) to fulvestrant (500 mg intramuscular injection; on days 0, 14, 28, then every 28 days thereafter) or anastrozole (1 mg orally daily) using a computer-generated randomisation scheme. The primary endpoint was progression-free survival, determined by Response Evaluation Criteria in Solid Tumors version 1 . 1, intervention by surgery or radiotherapy because of disease deterioration, or death from any cause, assessed in the intention-to-treat population. Safety outcomes were assessed in all patients who received at least one dose of randomised treatment (including placebo). This trial is registered with ClinicalTrials. gov, number NCT01602380.Findings Between Oct 17, 2012, and July 11, 2014, 524 patients were enrolled to this study. Of these, 462 patients were randomised (230 to receive fulvestrant and 232 to receive anastrozole). Progression-free survival was significantly longer in the fulvestrant group than in the anastrozole group (hazard ratio [HR] 0 . 797, 95% CI 0 . 637-0 . 999, p=0 . 0486). Median progression-free survival was 16 . 6 months (95% CI 13 . 83-20 . 99) in the fulvestrant group versus 13 . 8 months (11 . 99-16 . 59) in the anastrozole group. The most common adverse events were arthralgia (38 [17%] in the fulvestrant group vs 24 [10%] in the anastrozole group) and hot flushes (26 [11%] in the fulvestrant group vs 24 [10%] in the anastrozole group). 16 (7%) of 228 patients in in the fulvestrant group and 11 (5%) of 232 patients in the anastrozole group discontinued because of adverse events.Interpretation Fulvestrant has superior efficacy and is a preferred treatment option for patients with hormone receptor-positive locally advanced or metastatic breast cancer who have not received previous endocrine therapy compared with a third-generation aromatase inhibitor, a standard of care for first-line treatment of these patients. PB Elsevier science inc SN 0140-6736 YR 2016 FD 2016-12-17 LK http://hdl.handle.net/10668/18892 UL http://hdl.handle.net/10668/18892 LA en DS RISalud RD Apr 7, 2025