FALCON: A phase III randomised trial of fulvestrant 500 mg vs. anastrozole for hormone receptor-positive advanced breast cancer

Ellis, M.J. and Bondarenko, I. and Trishkina, E. and Dvorkin, M. and Panasci, L. and Manikhas, A. and Shparyk, Y. and Cardona-Huerta, S. and Cheung, K-L. and Philco-Salas, M.J. and Ruiz-Borrego, M. and Shao, Z. and Noguchi, S. and Grinsted, L.M. and Fazal, M. and Stuart, M. and Robertson, J.F. (2016) FALCON: A phase III randomised trial of fulvestrant 500 mg vs. anastrozole for hormone receptor-positive advanced breast cancer. Annals of Oncology, Vol.27 (supp6). P.-LBA14_PR. ISSN 0923-7534 (Print), 1569-8041 (Electronic)

[img]
Preview
Text
FALCONArticle Navigation.pdf

Download (361kB) | Preview
Official URL: https://doi.org/10.1093/annonc/mdw435.04

Abstract

Background: This Phase III, randomised, double-blind, multicentre trial (FALCON; NCT01602380) compared the selective estrogen receptor (ER) degrader (SERD) fulvestrant with anastrozole in patients with ER- and/or progesterone receptor-positive locally advanced or metastatic breast cancer who had not received prior hormonal therapy. Methods: Patients were randomised 1:1 to fulvestrant (500 mg IM on Days 0, 14, 28, then each 28 days) or anastrozole (1 mg daily). The primary endpoint was progression-free survival (PFS), assessed via RECIST 1.1, surgery/radiotherapy for disease worsening, or death. Secondary endpoints were: overall survival (OS); objective response rate (ORR, complete response [CR] or partial response [PR]); duration of response (DoR); expected DoR (EDoR); clinical benefit rate (CBR; CR, PR, or stable disease ≥24 weeks); duration of clinical benefit (DoCB); expected DoCB (EDoCB); health-related quality of life (HRQoL); and safety.

Item Type: Article
Subjects: Oncology
Divisions: Departments > Department of Oncology and Medical Radiology
Depositing User: Елена Шрамко
Date Deposited: 20 Sep 2017 11:35
Last Modified: 20 Sep 2017 11:35
URI: http://repo.dma.dp.ua/id/eprint/1960

Actions (login required)

View Item View Item