NCT06639672

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

Neoadjuvant Chemotherapy Combined With PD-1 Inhibitor and Different Radiotherapy Fractionations for HR+/HER2- Breast Cancer: A Phase II Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Lei Liu · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HR+HER2- Breast Cancer

Interventions

Type	Name	Description
DRUG	Chemotherapy+PD-1 inhibitor+8Gy x 3f	Radiotherapy: 8Gy x 3f, once every other day; Chemotherapy: Cycles 1-4: Albumin-bound paclitaxel: 260 mg/m², IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin: 90-100 mg/m², IV, administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV, administered on day 1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three weeks
DRUG	Chemotherapy+PD-1 inhibitor+16Gy x 1f	Radiotherapy: 16Gy x 1f; Chemotherapy: Cycles 1-4: Albumin-bound paclitaxel: 260 mg/m², IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin: 90-100 mg/m², IV, administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV, administered on day 1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three weeks
DRUG	Chemotherapy+PD-1 inhibitor+2.67Gy x 15f	Radiotherapy: 2.67Gy x 15f; Chemotherapy: Cycles 1-4: Albumin-bound paclitaxel: 260 mg/m², IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin: 90-100 mg/m², IV, administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV, administered on day 1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three weeks
DRUG	Chemotherapy+PD-1 inhibitor+0.5Gy x 12-18f	Radiotherapy: 0.5Gy x 12-18f; Chemotherapy: Cycles 1-4: Albumin-bound paclitaxel: 260 mg/m², IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin: 90-100 mg/m², IV, administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV, administered on day 1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three weeks

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-05-01
• Completion: 2031-05-01
• First posted: 2024-10-15
• Last updated: 2024-10-15