OncRef

Clinical Trial: NCT06639672

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

Status:

NOT YET RECRUITING

Phase:

Phase 2

Lead Sponsor:Lei Liu
Information Provided By:West China Hospital
Last Update Posted:2024-10-15

Study Overview

Brief 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.

Official Title

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

Conditions

HR+HER2- Breast Cancer

Intervention / Treatment

  • Drug: Chemotherapy+PD-1 inhibitor+8Gy x 3f
  • Drug: Chemotherapy+PD-1 inhibitor+16Gy x 1f
  • Drug: Chemotherapy+PD-1 inhibitor+2.67Gy x 15f
  • Drug: Chemotherapy+PD-1 inhibitor+0.5Gy x 12-18f

Other Study ID Numbers

  • 20241777

Start Date (Estimated)

2024-11-01

Primary Completion Date (Estimated)

2026-05-01

Study Completion Date (Estimated)

2031-05-01

Enrollment (Estimated)

60

Study Type

Interventional

Phase

Phase 2