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Combination endocrine therapy with an AI and 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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Conflicting results were found in two trials that compared the combination of the antiestrogen fulvestrant and anastrozole with anastrozole alone in the first-line treatment of hormone receptor–positive postmenopausal patients with recurrent or metastatic disease. For more information, see the Fulvestrant section.[48,49] In both studies, fulvestrant was given as a 500-mg loading dose on day 1; 250 mg was given on days 15 and 29, and monthly thereafter; plus, 1 mg of anastrozole was given daily. The Southwest Oncology Group (SWOG) trial included more patients who presented with metastatic disease; the Fulvestrant and Anastrozole Combination Therapy (FACT [NCT00256698]) study enrolled more patients who had previously received tamoxifen.[48,49]
Evidence (combination endocrine therapy with an AI and fulvestrant):
The SWOG-0226 trial (NCT00075764), which enrolled 707 patients, demonstrated a statistically significant difference in PFS (HR, 0.80; 95% CI, 0.68–0.94; P = .007) and OS (HR, 0.81; 95% CI, 0.65–1.00; P = .05).[48][Level of evidence A1]
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In an analysis done after 5 more years of follow-up, the observed benefits of combined therapy were still present, and the level of significance with respect to OS was greater (HR, 0.82; 95% CI, 0.69–0.98; P = .03).[50][Level of evidence A1]
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In contrast, the FACT trial, which enrolled 514 patients, found no difference in either disease-free survival (DFS) (HR, 0.99; 95% CI, 0.81–1.20; P = .91) or OS (HR, 1.0; 95% CI, 0.76–1.32; P = 1.00).[49][Level of evidence A1]
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