Last reviewed · How we verify
Prospective, Single-arm, Phase II Study of Stereotactic Radiotherapy Combined with PD-1 Monoclonal Antibody and Chemotherapy As Neoadjuvant Treatment for Triple-negative Breast Cancer
The primary aim is to evaluate the efficacy of neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy in patients with triple-negative breast cancer, with the endpoint being the pCR rate-defined as the proportion of patients with no residual invasive cancer in the breast and no axillary lymph node metastasis after treatment. This is a single-arm study. Eligible participants will receive : neoadjuvant treatment consisting of SBRT followed by Envafolimab (PD-1 inhibitor), chemotherapy and immunotherapy (Envafolimab). Surgery will be performed after the last chemotherapy cycle. Pathological evaluation will assess the treatment response. Patients will receive adjuvant immunotherapy (Envafolimab) up to 1 year post-surgery.
Details
| Lead sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
|---|---|
| Phase | Phase 2 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 20 |
| Start date | 2025-02 |
| Completion | 2030-11 |
Conditions
- Breast Cancer Invasive
Interventions
- neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy
Primary outcomes
- the efficacy of neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy — From enrollment to the completion of surgery
pCR rate-defined as the proportion of patients with no residual invasive cancer in the breast and no axillary lymph node metastasis after treatment