RecruitingPhase 2NCT06671262

Neoadjuvant Toripalimab and Radiotherapy Treatment in N+ HR+ Breast Cancer

Neoadjuvant Toripalimab and Radiotherapy Treatment in Lymph Nodes Positive HR Positve Breast Cancer(NEOTRIO-HR)


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

74 participants

Start Date

Dec 26, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to compare the efficacy and safety in patients with lymph node-positive HR+/HER2- breast cancer. The main questions it aims to answer are: * Can the incorporation of intensified radiation to the tumor (tumor boost) enhance the pCR rate on the basis of neoadjuvant immuno-chemotherapy? * Can it improve the level of residual cancer burden (RCB) and change the tumor immune microenvironment? and How safe will be the combined therapy? Participants will be randomly assigned to one of three treatment regimens: 1. Preoperative toripalimab combined with SBRT targeting both the primary tumor and axillary lymph nodes, followed by chemotherapy; 2. Preoperative toripalimab combined with SBRT focused solely on the primary tumor, followed by chemotherapy; 3. Preoperative toripalimab combined with chemotherapy alone. Following the completion of their respective treatment regimens, participants will proceed to undergo surgery. The effectiveness of the treatments will be assessed through pathological evaluations, as well as by measuring levels of residual cancer burden (RCB) and examining changes in the tumor immune microenvironment. The study aims to evaluate the safety of these combined treatment approaches and to determine if they offer superior efficacy compared to outcomes reported in previous studies.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug (toripalimab) to radiation therapy before surgery improves outcomes for women with a high-risk type of breast cancer (hormone receptor-positive, HER2-negative) that has spread to the lymph nodes. **You may be eligible if...** - You have hormone receptor-positive (HR+), HER2-negative breast cancer that is stage II or III - Your cancer has spread to underarm lymph nodes, confirmed by biopsy - Your tumor's PD-L1 score is below 10 - Your general health (ECOG score) is 0 or 1, meaning you are fully active or have only minor limitations - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have signs of cancer spreading to distant organs - Your cancer is HER2-positive or lacks hormone receptors - You have significant autoimmune conditions or are on immunosuppressive medications - Your blood counts or organ function do not meet the study requirements 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

RADIATIONSBRT

Target the primary tumor region with a single dose of 8Gy, or deliver a dose of 3Gy to the axillary lymph nodes, administered once a day for three consecutive days.

DRUGImmuno-chemotherapy

Standard new adjuvant treatment with toripalimab combined with chemotherapy, that is in the first phase consisting of paclitaxel and toripalimab for four cycles, followed by epirubicin, cyclophosphamide, and toripalimab for another four cycles.


Locations(1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

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NCT06671262


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