The management of HR-positive, HER2-negative metastatic breast cancer includes endocrine monotherapy or combination regimens, both with benefit diminishing as resistance develops. Nowadays, various studies have demonstrated that estrogen interacts with many angiogenic pathways and is an important mechanism for resistance leading to the question of whether combination with antiangiogenesis and antiestrogen therapies could be an appropriate therapeutic modality. Anlotinib is a novel multi-target tyrosine kinase inhibitor that effectively inhibit VEGFR, FGFR, PDGFR, c-KIT, c-MET and RET. Previous studies have proven the efficacy of both anlotinib monotherapy and combination regimens in advanced breast cancer. This phase II study aims to preliminarily evaluate the efficacy and safety of anlotinib combined with endocrine therapy.
Aged 18 years or older female；
ECOG score 0-1;
Life expectancy is not less than 12 weeks;
Histology confirmed HR-positive and HER2-negative locally advanced or metastatic breast cancer;
Have received prior fulvestrant or anti-angiogenic drug treatment, or known to be allergic to any excipients in the study;
Visceral crisis;
Uncontrolled or high-burden CNS metastases;
Unable to swallow;
Single group
anlotinib, fulvestrant
Druganlotinib: 12 mg once daily on days 1-14, repeated every 21 days; fulvestrant: 500 mg on days 1 and 15 of cycle one, and then on day one of each subsequent 28 days cycle
Progression-Free Survival
Time from randomisation to tumour progression (in any way) or death (from any cause)
Overall Response Rate
Confirmed complete response or partial response according to RECIST 1.1
Clinical Benefit Rate
Confirmed complete response or partial response or stable disease of 24 weeks' duration or longer
Overall Survival
Time from randomisation to death (from any cause)
Adverse events
Adverse events occurred from randomisation to 30 days after the last dose administrated
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