This is a prospective, single-arm, multicenter study to observe and evaluate the efficacy and safety of paclitaxel polymeric micelles and carboplatin in combination with iparomilimab and tuvonralimab in neoadjuvant therapy for triple-negative breast cancer. The main endpoint of the study is pCR, 32 patients are scheduled to be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
paclitaxel polymeric micelles 300mg/m2, d1 carboplatin AUC=5, d1 iparomilimab and tuvonralimab 5mg/kg, d1 Every 3 weeks (Q3W) is a cycle, a total of 6 cycles.
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Primary endpoint
Pathological complete response (pCR) rates in patients with triple-negative breast cancer
Time frame: After surgery(within 1 month)
Objective response rate (ORR)
Time frame: During neoadjuvant therapy before surgery(within 6 months)
The rate of event-free Survival (EFS)
Time frame: 2-year
The incidence of treatment-related adverse event
Time frame: 2-year
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