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.
Age: 18-70 years.
Disease Status: Clinical pathological confirmation of cT2-cT4d, or cT1c with axillary lymph node metastasis.
Pathology: Histopathologically confirmed triple-negative, invasive breast carcinoma.
ER and PR negative (IHC nuclear staining <10%).
Metastatic Disease: Evidence of metastatic breast cancer. (To exclude metastasis, CT scans of the chest and abdomen, and a bone scan must be performed at any time point from diagnosis to randomization; PET/CT may serve as an alternative imaging modality).
Prior Anti-Cancer Therapy: Any prior chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for the current breast cancer.
Adequately treated non-melanoma skin carcinoma.
Prior Immunotherapy: Previous treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or any other immunomodulatory therapy.
Parallel
Toripalimab
DrugToripalimab 240mg every cycle
PCb-EC
DrugAlbumin Paclitaxel + Carboplatin\*4 Followed by Epirubicin + Cyclophosphamide\*4
PCb
DrugAlbumin Paclitaxel + Carboplatin \*6
Pathologic complete response (pCR) rates
Objective response rate（ORR）
Event-free survival (EFS)
Invasive Disease-Free Survival (IDFS)
Overall Survival (OS)
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This trial is not recruiting at the moment. You can still explore other options:
