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RecruitingPhase 2NCT06705127

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

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.

Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

30 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

HR-positive,HER2-negative Breast Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug (toripalimab, a type of checkpoint inhibitor) to standard radiation therapy and chemotherapy improves outcomes in people with hormone receptor-positive, HER2-negative breast cancer that has spread to nearby lymph nodes. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with invasive breast cancer that is hormone receptor-positive (ER ≥1%), HER2-negative, and aggressive (Grade 3, Ki-67 >20%) confirmed by biopsy - Your cancer is locally advanced but has not spread to distant organs (T1c-T4, N0-N2, M0) - You have not received any prior treatment for this breast cancer - You are in good physical condition (ECOG performance status 0-1) **You may NOT be eligible if...** - You have a known allergy to anti-PD-1 immunotherapy drugs - You are currently participating in another treatment study - You have already received systemic chemotherapy or targeted therapy for breast cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTORIPALIMAB 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.

RADIATIONStereotactic 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

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NCT06705127

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