The study will evaluate the safety and tolerability of fulvestrant 500mg compared to anastrozole 1mg in 450 postmenopausal patients with hormone receptor-positive advanced breast cancer and those who were not exposed to any hormonal therapy previously.
AstraZeneca medical science director Yuri Rukazenkov said despite advances in treatment and detection, breast cancer remains the primary cause of cancer death in women around the world.
"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 optimizing breast cancer therapies for all patient groups," Rukazenkov added.
The double-blind, parallel group, multicenter study is designed to randomize subjects in 1:1 ratio with either fulvestrant on days 0, 14 (±3), 28 (±3), and every 28 (±3) days subsequently with a placebo to match the anastrozole administration program, or anastrozole along with a placebo to go with the fulvestrant delivery.