Cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors combined with hormonal therapy are the current standard frontline treatment for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER-2)-negative metastatic breast cancer (MBC). However, the optimal treatment after progression on CDK4/6 inhibitors remains unknown. Anlotinib is an oral multi-target tyrosine kinase inhibitor (TKI) that strongly inhibits VEGFR, PDGFR, FGFR, and c-kit. This study aimed to evaluate the safety and efficacy of anlotinib-based combination therapy in patients with HR+ MBC previously treated with a CDK4/6 inhibitor.
Study Type
OBSERVATIONAL
Enrollment
80
Anlotinib (8/10/12 mg daily, Day 1-14 of each cycle) was administered orally to fasting patients, with dose reductions to 10 mg or 8 mg in cases of intolerable toxicity. Combination agents included eribulin, nab-paclitaxel, etoposide, capecitabine, pembrolizumab, sintilimab, or fulvestrant, among others.
Hunan Provincial Tumor Hospital
Changsha, Hunan, China
RECRUITINGProgression free survival (PFS)
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
Time frame: through study completion, an average of 1 year
Objective response rate (ORR)
The ORR will be defined as the proportion of patients in the Efficacy Evaluable patient Set who achieve complete response (CR) and partial response (PR)
Time frame: through study completion, an average of 1 year
Disease control rate (DCR)
The DCR will be defined as the proportion of patients in the Efficacy Evaluable patient Set who achieve complete response (CR) or partial response (PR) or stable disease (SD).
Time frame: through study completion, an average of 1 year
Overall survival(OS)
OS, defined as the time from the date of informed consent until to the date of death, regardless of the cause of death.
Time frame: through study completion, an average of 5 year
Incidence of Treatment-Emergent Adverse Events (Safety)
All the treatment-related adverse events occurred as assessed by CTCAE v4.0
Time frame: through study completion, an average of 1 year
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