Clinical Trial: NCT06639672
Neoadjuvant Chemotherapy + PD-1 Inhibitor+Different Radiotherapy Fractionations for HR+/HER2- Breast Cancer
Status:
NOT YET RECRUITINGPhase:
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
Conditions
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)
Primary Completion Date (Estimated)
Study Completion Date (Estimated)
Enrollment (Estimated)
Study Type
Phase
| 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
Conditions
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