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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

November 1, 2024

Primary Completion Date

May 1, 2026

Study Completion Date

May 1, 2031

Conditions
HR+HER2- Breast Cancer
Interventions
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

All Listed Sponsors
lead

Lei Liu

OTHER

NCT06639672 - Neoadjuvant Chemotherapy + PD-1 Inhibitor+Different Radiotherapy Fractionations for HR+/HER2- Breast Cancer | Biotech Hunter | Biotech Hunter