This study aims to evaluate the efficacy and safety of a PD-1 inhibitor combined with different chemotherapy regimens (PCb-EC and PCb), in order to develop a superior and well-tolerated neoadjuvant therapeutic strategy for patients with triple-negative breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
216
Toripalimab 240mg every cycle
Albumin Paclitaxel + Carboplatin\*4 Followed by Epirubicin + Cyclophosphamide\*4
Albumin Paclitaxel + Carboplatin \*6
Pathologic complete response (pCR) rates
Time frame: Up to 180 days
Objective response rate(ORR)
Time frame: up to 180 days
Event-free survival (EFS)
Time frame: up to 5 years
Invasive Disease-Free Survival (IDFS)
Time frame: up to 5 years
Overall Survival (OS)
Time frame: up to 5 years
Adverse events
Time frame: up to 18 months
EORTC QLQ-C30 questionnaire
All of the scales and single-item measures range in score from 0 to 100. A high scale scorerepresents a higher response level
Time frame: up to 18 months
EORTC QLQ-BR23 questionnaire
All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning,
Time frame: up to 18 months
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