The hypothesis of this study is to discover if the oral Etoposide plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC. It is a single-arm, multicenter phase II clinical study of oral etoposide combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer
It is a single-arm, multicenter phase II clinical study of oral etoposide combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer. The hypothesis of this study is to discover if the oral Etoposide plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
anlotinib 12mg qd, d1-14,21days/cycle oral etoposide 75mg qd,d1-10,21days/cycle
Cancer Institute & Hospital. Chinese Academy of Medical Sciences
Beijing, China
RECRUITINGobjective 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: up to 1 year after the last patient enrolled
Progression free survival(PFS)
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
Incidence and Severity of adverse events
hematologic,hepatotoxicity,Incidence of hypertension,Incidence of proteinuria
Time frame: approximately 1.5 years
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