NCT05475678

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

A Randomized, Open Label, Parallel Controlled, Multicenter Phase II Clinical Study of Carelizumab Combined With TCb (Docetaxel+Carboplatin) Versus TCb Neoadjuvant Therapy for Triple Negative Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 369 (estimated)
• Sponsor: Zhenzhen Liu · Other Government
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study mainly compared the efficacy and safety of 6\*TCb (docetaxel+carboplatin)+carrelizumab regimen and 6\*TCb regimen in neoadjuvant chemotherapy for triple-negative breast cancer. Patients who met the inclusion criteria were randomly assigned to the experimental group and the control group in a 2:1 ratio. * The experimental group received 6 cycles of TCb+carrelizumab (docetaxel 75mg/m2 on the first day + carboplatin AUC=6, on the first day; camrelizumab 200mg on the third day) regimen neoadjuvant chemotherapy, every 21 days is a cycle. * The control group received 6 cycles of TCb (docetaxel 75mg/m2 on the first day + carboplatin AUC=6 on the first day) regimen neoadjuvant chemotherapy, every 21 days as a cycle. The efficacy and safety of the two chemotherapy regimens on neoadjuvant chemotherapy for triple-negative breast cancer were evaluated by PCR, EFS, DFS, DDFS and ORR after surgery.

Conditions

• Breast Cancer
• Triple Negative Breast Cancer
• Camrelizumab

Interventions

Type	Name	Description
DRUG	（Carrelizumab + TCb） regimen	Carrelizumab +docetaxel + carboplatin regimen
DRUG	TCb regimen	docetaxel + carboplatin regimen

Timeline

• Start date: 2022-12-20
• Primary completion: 2025-05-31
• Completion: 2029-12-31
• First posted: 2022-07-27
• Last updated: 2025-01-23

Locations

1 site across 1 country: China