AstraZeneca announced preliminary results from the Phase 3 FALCON study, evaluating fulvestrant vs. anastrozole for the treatment of locally-advanced or metastatic breast cancer, in postmenopausal women who have not had prior hormonal treatment for hormone receptor positive (HR+) breast cancer.

FALCON (Fulvestrant and AnastrozoLCOmpared in hormonal therapy Naïve advanced breast cancer) is a randomized, double-blind, multicenter Phase 3 trial comparing the anti-tumor effects and tolerability profile of fulvestrant 500mg plus placebo to anastrozole 1mg plus placebo in postmenopausal women with HR+, locally advanced or metastatic breast cancer previously untreated with any hormonal therapy. The primary endpoint was extended progression-free-survival. 

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Preliminary results showed that treatment with fulvestrant 500mg demonstrated superiority over anastrozole 1mg, meeting the study’s primary endpoint. Tolerability profiles for both regimens were generally consistent with current safety knowledge. A full evaluation of the data is ongoing and detailed results are expected to be presented at an upcoming medical congress.

Aromatase inhibitors, including anastrozole, are a standard of care in first-line treatment for postmenopausal women with advanced HR+ positive breast cancer.

Fulvestrant is an estrogen receptor antagonist currently approved for the treatment of HR+ metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy. Recently, it also received FDA approval for the treatment of HR+, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in women with disease progression after endocrine therapy, in combination with palbociclib.

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