Clinical Study of Camrelizumab Combined With TCb Versus TCb in Neoadjuvant Treatment of Triple-negative Breast Cancer

Triple-negative breast cancer (TNBC) is a special subtype of breast cancer that lacks the expression of ER, PR, and Her-2 proteins, accounting for 15%-20% of all breast cancers.TNBC patients do not benefit from endocrine therapy or HER-2-targeted therapy, but are sensitive to cytotoxic drug therapy.Although the survival of TNBC patients has improved significantly compared with the past, it is still the type with the worst prognosis among all subtypes of breast cancer. Methods and drugs to further improve the therapeutic effect of TNBC patients are still being explored. Camrelizumab, a PD-1 inhibitor produced by Hengrui, has been approved for the treatment of various malignant tumors including advanced lung cancer, advanced liver cancer and advanced esophageal cancer. Shows good therapeutic effect and safety. Therefore, this study intends to explore the superiority of camrelizumab on the basis of the less toxic anthracycline-free TCb regimen.In order to provide more effective and safe neoadjuvant therapy for lymph node-positive TNBC patients.

NCT Number	NCT05475678
Lead Sponsor	Zhenzhen Liu
Conditions	Breast Cancer, Triple Negative Breast Cancer, Camrelizumab
Enrollment	369 participants
Start Date	2022-12-20
Primary Completion	2025-05-31 (estimated)
Study Completion	2029-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-01-23