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RECRUITING
NCT06705127
PHASE2

Radiotherapy Followed by Chemotherapy Combined With Toripalimab in Local Advanced HR-positive,HER2-negative BC.

Sponsor: First Affiliated Hospital of Zhejiang University

View on ClinicalTrials.gov

Summary

This study is the first to explore the clinical study of neoadjuvant radiotherapy followed by chemotherapy combined with terriplizumab in breast cancer. Participants with locally advanced (T1c-T2(≥2cm) N1-2M0 or T3-4cN0-2M0) HR-positive and HER2-negative breast cancer were enrolled to evaluate the efficacy and safety of neoadjuvant radiotherapy followed by chemotherapy combined with triplimab in the treatment of locally advanced HR-positive and HER2-negative breast cancer. About 30 participants are planned to participate in this clinical study.

Official title: A Phase II,Single-arm,Multicenter Study of Radiotherapy Followed by Chemotherapy Combined With Toripalimab Immunotherapy in Local Advanced HR-positive,HER2-negative Breast Cancer.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-07-01

Completion Date

2028-07-01

Last Updated

2024-11-26

Healthy Volunteers

No

Interventions

DRUG

TORIPALIMAB INJECTION(JS001 )

Drug A: 240mg intravenous infusion of Toripalimab, once every 3 weeks, the first dosing date was C1D1, followed by the first day of each course for 18 cycles, a total of 1 year. Drugs B and C: Epirubicin was administered intravenously after the dosage was calculated at 90mg/m2 body surface area, cyclophosphamide was calculated at 600mg/m2 body surface area by intravenous micropump, both drugs were administered every 3 weeks, the first administration date was C1D1, and then the first day of each course was administered for 4 cycles. Drug D:albumin paclitaxel was given intravenatically at a dose of 125mg/m2 body surface area, once a week, with the first administration date of C5D1, and then on the first day of each course for 12 cycles.

RADIATION

Stereotactic Body Radiation Therapy (SBRT)

Local radiotherapy: Subjects received stereotactic radiotherapy for the primary breast cancer lesion at 8Gy each time for 3 consecutive days, once a day, 2 weeks before the start of systemic therapy

Locations (1)

the First Affiliated Hospital,Zhejiang University School of Medicine

Hangzhou, Zhejiang, China