The hypothesis of this clinical research study is to discover if the study drug apatinib can shrink or slow the growth of pretreated metastatic triple-negative breast cancer.
Apatinib is a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor (VEGFR), and its anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The hypothesis of this clinical research study is to discover if the study drug apatinib can shrink or slow the growth of triple-negative breast cancer. The safety of apatinib will also be studied. Patients physical state, symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if apatinib is safe and effective in pretreated metastatic triple-negative breast cancer patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Apatinib was administratered at 750 mg/d in Phase IIa. The actual average dose intensity delivered was 525 mg/d due to toxicities. So, in Phase IIb, the starting dose of apatinib will be 500mg/d. Two dose reductions will be allowed to 375 and then 250 mg/d.
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
DCR(Disease control rate) for IIa
Time frame: 8 Weeks
PFS(Progression free survival) for IIb
Time frame: 8 Weeks
PFS(Progression free survival) for IIa
Time frame: 8 Weeks
OS (Overall survival)
Time frame: 8 Weeks
ORR (Objective response rate)
Time frame: 8 Weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 8 weeks
QoL (Quality of life)
Time frame: 8 Weeks
DCR(Disease control rate) for IIb
Time frame: 8 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.