Fulvestrant as maintenance therapy after first-line chemotherapy in postmenopausal hormone receptor-positive, HER2-negative advanced breast cancer patients (FANCY): A prospective, multicenter, single arm phase II study.
Journal of Clinical Oncology(2016)
摘要
1066Background: Fulvestrant is potent for treatment of hormone receptor (HR)-positive advanced breast cancer (ABC); however, few data exist for this regimen as maintenance endocrine treatment after chemotherapy (CT). In our phase 2 trial, we aimed to assess efficacy and tolerability of fulvestrant 500mg as maintenance therapy in patients with disease control after first-line CT. Methods: Simon’s two-stage design was used. We enrolled postmenopausal women with histologically confirmed HR-positive, HER2-negative ABC, who achieved disease control after four to eight cycles of first-line CT. Fulvestrant 500 mg was intramuscularly injected on day 1, 15, 29, then every 28 (±3) days subsequently, until disease progression or unacceptable toxicity. The primary endpoint was clinical benefit rate (CBR), secondary endpoint included progression-free survival (PFS) since maintenance treatment, PFS since first-line CT, objective response rate (ORR) and safety. Results: Between Dec 10, 2013, and Sept 30, 2015, 58 patien...
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