drugset / Trial / NCT05749575

Chidamide Plus PD-1 Plus Paclitaxel of Neoadjuvant Treatment in Low HR Expression,HER2-negative Early Breast Cancer.

NCT05749575 ↗

Phase 2 Unknown 28 enrolled Sun Yat-sen University
NaSingle-groupOpen-labelTreatment

Summary

Triple-negative breast cancer has always been a difficult problem in clinical practice because of its young onset age, high aggressiveness, no clear therapeutic target and poor clinical prognosis. The treatment of triple-negative breast cancer is mainly chemotherapy, and in order to break the current dilemma, new treatments must be introduced. Immunotherapy is one of the most high-profile treatments. The KEYNOTE-522 study and Impassion 031 Study have found that immunotherapy can significantly improve the pCR of patients with triple yin breast cancer, rate, independent of PD-L1 expression status, and good safety.Cedardenamine is a histone deacetylation (HDAC) inhibitor developed in China.Many studies suggest that the use of sidabamine will likely enhance the efficacy of PD-1 / PD-L1 mAb in breast cancer and expand the use of PD-1 / PD-L1 mAb in the beneficiary population of breast cancer

Timeline

Start
2023-02
Primary completion
2023-08
Completion
2024-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Paclitaxel Small molecule 175 mg/m2 Intravenous
Subject Toripalimab Monoclonal antibody 240 mg Intravenous
Subject Tucidinostat Small molecule 20 mg —

Indications