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HEALTH PROFESSIONAL · SOURCE READING

First-line fulvestrant

Source: Breast Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.

Source updated: April 25, 2025 · Captured 2026-09-09.

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Context: Treatment of Metastatic Breast Cancer / Metastatic HER2-Negative Hormone Receptor–Positive Breast Cancer / Endocrine therapy alone / Fulvestrant

Evidence (first-line fulvestrant):

FALCON (NCT01602380) was a phase III, double-blind, randomized trial that compared fulvestrant (500 mg) with anastrozole (1 mg) in patients with advanced or metastatic receptor-positive breast cancer who had not received previous endocrine therapy.[41] The trial randomly assigned 230 patients to receive fulvestrant and 232 patients to receive anastrozole.

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FALCON (NCT01602380) was a phase III, double-blind, randomized trial that compared fulvestrant (500 mg) with anastrozole (1 mg) in patients with advanced or metastatic receptor-positive breast cancer who had not received previous endocrine therapy.[41] The trial randomly assigned 230 patients to receive fulvestrant and 232 patients to receive anastrozole.

Median PFS was 16.6 months in the fulvestrant group and 13.8 months in the anastrozole group (HR, 0.797; 95% CI, 0.637−0.999; P = .049).[41][Level of evidence B1]

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FALCON (NCT01602380) was a phase III, double-blind, randomized trial that compared fulvestrant (500 mg) with anastrozole (1 mg) in patients with advanced or metastatic receptor-positive breast cancer who had not received previous endocrine therapy.[41] The trial randomly assigned 230 patients to receive fulvestrant and 232 patients to receive anastrozole.

The frequency of adverse events was similar in the two groups, and there was no difference in quality of life.

FALCON (NCT01602380) was a phase III, double-blind, randomized trial that compared fulvestrant (500 mg) with anastrozole (1 mg) in patients with advanced or metastatic receptor-positive breast cancer who had not received previous endocrine therapy.[41] The trial randomly assigned 230 patients to receive fulvestrant and 232 patients to receive anastrozole.

OS results were not reported.

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Preserved source evidence · Not medical advice