This study aims to investigate efficacy and safety of neoadjuvant toripalimab plus docetaxel and carboplatin in patients with localized triple-negative breast cancer.
Neoadjuvant chemotherapy combined with immunotherapy is the recommended therapeutic approach for patients with localized triple-negative breast cancer (TNBC). The combination regimen improved the pCR rate of triple negative breast cancer, but its side effects also increased. In the KEYNOTE-522 trial, 78% of patients receiving pembrolizumab combined with anthracycline and paclitaxel chemotherapy experienced grade 3 or higher adverse reactions, while the incidence of grade 3 or higher adverse events for patients receiving tislelizumab plus nab-paclitaxel and carboplatin in the CTRIO study was 53.2%. Toripalimab (an anti PD-1 monoclonal) combined with paclitaxel (albumin binding type) for first-line treatment of recurrent or metastatic TNBC was recently approved based on the results from the TORCHLIGHT study. This study aims to investigate efficacy and safety of neoadjuvant toripalimab plus docetaxel and carboplatin in patients with localized TNBC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Toripalimab was given 240 mg intravenously on day 1 of each 21-day cycle for 6 cycles.
Docetaxel was administered at a dose of 75 mg/m2 on day 1 of each 21-day cycle for 6 cycles.
Carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 4 on day 1 of each 21-day cycle for 6 cycles.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Pathological complete response (pCR) rate
The number of patients with pCR out of the total number of participants using a definition of ypT0/Tis ypN0 after neoadjuvant therapy and surgery.
Time frame: 1 week after surgery
Rate of Residual Cancer Burden (RCB) of 0-1
The number of patients with RCB of 0-1 after neoadjuvant therapy and surgery.
Time frame: 1 year
Objective Response Rate (ORR)
The number of patients with complete response and partial response out of the total number of participants.
Time frame: 1 year
Event-Free Survival (EFS)
EFS was defined as the time from registration to disease progression (local relapse or distant metastases) or death from any cause, whichever came first.
Time frame: 3 years after the last patient is enrolled
Safety of the combination therapy
Adverse events (AEs) were graded according to NCI CTCAE v5.0.
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.