drugset / Trial / NCT06639672

Neoadjuvant Chemotherapy + PD-1 Inhibitor+Different Radiotherapy Fractionations for HR+/HER2- Breast Cancer

NCT06639672

Phase 2 Not yet recruiting 60 enrolled Lei Liu
Non-randomizedParallel-groupOpen-labelTreatment

Summary

For the hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) subtype of breast cancer, although surgical, radiotherapy, and endocrine treatments have shown better survival, this subtype has a relatively poor response to neoadjuvant chemotherapy and immunotherapy, with an approximately pCR of 20%. The low immunogenicity result in suboptimal pCR and objective response rates for this group. Therefore, there is an urgent need to explore new, highly effective, and low-toxicity treatment strategies to further improve the efficacy of HR+/HER2- breast cancer. Radiotherapy has systemic immune regulatory effects by promoting the release of antigens from tumor cells, enhancing T-cell infiltration, and directly killing tumor cells. Therefore, this study aims to investigate the efficacy and safety of chemotherapy combined with PD-1 inhibitor and different radiotherapy fractionations in the neoadjuvant treatment of HR+/HER2- breast cancer.

Timeline

Start
2024-11-01
Primary completion
2026-05-01
Completion
2031-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Subject Epirubicin Small molecule 90 mg/m2 Intravenous
Subject Epirubicin Small molecule 100 mg/m2 Intravenous
Subject Paclitaxel Small molecule 260 mg/m2 Intravenous