AstraZeneca has announced the commencement of its FALCON Phase III study evaluating fulvestrant in patients with hormone receptor-positive advanced breast cancer.
The study will determine the safety and tolerability profile of fulvestrant 500mg compared to anastrozole 1mg in 450 postmenopausal patients who were not previously treated with any hormonal therapy.
University of Nottingham Royal Derby Hospital, Graduate Entry Medicine and Health School professor of medicine Dr John Robertson said; "The FALCON study is the first Phase III study designed to investigate the potential role of the 500 mg dose of fulvestrant in the treatment of hormone receptor positive advanced breast cancer in patients who have not been previously treated with any hormonal therapy."
FALCON study is believed to show an impact on clinical practice relating to endocrine treatment options for women with hormone receptor-positive, locally advanced or metastatic breast cancer.
Safety and efficacy results from the Phase II FIRST study have formed the basis for FALCON's design.
The double-blind, parallel group, multicentre study will randomise subjects in 1:1 with either fulvestrant on days 0, 14 (±3), 28 (±3), and every 28 (±3) days afterwards, plus a placebo to match the anastrozole administration plan, or anastrozole plus a placebo to go with the fulvestrant administration.
AstraZeneca medical science director Dr Yuri Rukazenkov said; "The FALCON trial is part of AstraZeneca's commitment to the continued study and evaluation of treatment options for metastatic breast cancer, and developing and optimising breast cancer therapies for all patient groups."