Neoadjuvant Treatment of Triple-Negative Breast Cancer with Stereotactic Radiotherapy, PD-1 Monoclonal Antibody, and Chemotherapy

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

February 28, 2025

Primary Completion Date

November 30, 2028

Study Completion Date

November 30, 2030

Conditions
Breast Cancer Invasive
Interventions
RADIATION

neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy

"Eligible participants will receive neoadjuvant treatment consisting of:~SBRT: One session of 10Gy radiation to the primary tumor, followed by a 150mg subcutaneous injection of pembrolizumab (PD-1 inhibitor).~Chemotherapy and Immunotherapy: One week after SBRT, participants will undergo 6 cycles of pembrolizumab (400mg), albumin-bound paclitaxel (250mg/m²), and carboplatin (AUC=5).~Surgery: Surgery will be performed 21 days after the last chemotherapy cycle, with either breast-conserving surgery or modified radical mastectomy. Pathological evaluation will assess the treatment response.~Adjuvant Immunotherapy: Four weeks post-surgery, patients will receive pembrolizumab every 3 weeks for up to 1 year."

All Listed Sponsors
lead

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER