The hypothesis of this study is to discover if the capecitabine plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC. It is a single-arm phase II clinical study of capecitabine combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer
It is a single-arm phase II clinical study of capecitabine combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer. The hypothesis of this study is to discover if the capecitabine plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Before breakfast, anlotinib hydrochloride capsule was taken on an empty stomach, once a day, 1 tablet (10mg) each time.Continuous oral administration for 2 weeks stopped for 1 week, that is, 3 weeks (21 days) as a treatment cycle, until disease progression or adverse reactions become intolerable.In case of missing medication, confirm that the time before the next medication is less than 12 hours, no refill.
Capecitabine tablets 1000 mg/m2, twice a day, within 30min after meals, were taken orally for 2 consecutive weeks and stopped for 1 week, i.e., 3 weeks (21 days) as a treatment cycle until disease progression or adverse reactions became intolerable.
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGCancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
RECRUITINGObjective Response Rate
he 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: up to 1 year after the last patient enrolled
Progression-free survival
PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause
Time frame: up to 1 year after the last patient enrolled
adverse events
Incidence and Severity of adverse events hematologic,hepatotoxicity,Incidence of hypertension,Incidence of proteinuria
Time frame: approximately 1.5 years
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