The study is being conducted to evaluate VEGFR BP102 with nab-paclitaxe or treatment of physician's choice (TPC) versus nab-paclitaxe or TPC in patients for basal-like immune suppressed (BLIS) subtype of triple-negative breast cancer (TNBC) in the first-line teatment of unresectable locally advanced or metastatic TNBC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
134
VEGFR and TPC If patients were de novo or their disease-free interval (DFI) were more than or equal to 12 months and were randomized to experimental arm: VEGFR bevacizumab 10mg/kg d1,15 ivgtt + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle. Capecitabine with bevacizumab maintenance if intolerable toxicity was observed with no progression. Capecitabine maintenance 1000mg/m2 po bid d1-d14 every 3 weeks and bevacizumab 10mg/kg d1,15 ivgtt every 4 weeks. If patients' DFI were less than 12 months and were randomized to experimental arm: VEGFR bevacizumab 10mg/kg d1,15 ivgtt, every 4 weeks, + TPC (eribulin mesylate 1.4mg/m2 d1,8 iv, every 3 weeks / vinorelbine 25 mg/m2 d1,8 ivgtt , every 3 weeks/ capecitabine 1000mg/m2 po bid d1-d14 every 3 weeks /carboplatin AUC=6 d1 ivgtt, every 3 weeks / UTD1 30mg/m2 d1-5 ivgtt, every 3 weeks ).
If patients were de novo or their disease-free interval (DFI) were more than or equal to 12 months and were randomized to control arm: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle. Capecitabine maintenance if intolerable toxicity was observed with no progression. Capecitabine maintenance 1000mg/m2 po bid d1-d14 every 3 weeks. If patients' DFI were less than 12 months and were randomized to control arm: TPC (eribulin mesylate 1.4mg/m2 d1,8 iv, every 3 weeks / vinorelbine 25 mg/m2 d1,8 ivgtt , every 3 weeks/ capecitabine 1000mg/m2 po bid d1-d14 every 3 weeks /carboplatin AUC=6 d1 ivgtt, every 3 weeks / UTD1 30mg/m2 d1-5 ivgtt, every 3 weeks ).
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGPFS
time to progressive disease (according to RECIST1.1)
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 1.5 years)
ORR
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
Time frame: max 6 months
DoR
Duration of Overall Response.The date of the first assessed PR/CR (according to RECIST 1.1) to the date of the first assessed tumor progression (according to RECIST 1.1) or death from any cause.
Time frame: max 6 months
DCR
The percentage of subjects with CR+PR+SD and last more than 4 weeks in all of the participants with measurable lesions.
Time frame: max 6 months
OS
Time to death due to any cause
Time frame: approximately 3 years
Safety and tolerability
Adverse events according to NCI-CTCAE Version 5.0 per each treatment arm
Time frame: Approximately 3 years
Score of patient reported outcome (PRO)
Score of questionnaire by a report directly from a patient about his or her health or life quality.
Time frame: Approximately 3 years
Exploratory biomarkers
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The collected subjects' tumor tissues, paracancerous tissues, blood, and fecal samples will be used for discovering exploratory biomarkers.
Time frame: Approximately 3 years