RecruitingPhase 2NCT07457359

Neoadjuvant Toripalimab Plus SBRT for Chemo-Resistant Triple-Negative Breast Cancer

Neoadjuvant Toripalimab Combined With Preoperative Radiotherapy for Initial Chemotherapy-Nonresponding Triple-Negative Breast Cancer Patients (NEOTRIO-2)


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

18 participants

Start Date

Jan 4, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to test whether a "rescue" strategy can turn chemotherapy-resistant triple-negative breast cancer (TNBC) into a curable state. Patients whose tumors fail to shrink after 2 cycles of standard neoadjuvant chemotherapy will receive a short, high-precision course of stereotactic body radiotherapy (SBRT, 24 Gy in 3 daily fractions) to the breast primary tumor, followed by 4 cycles of toripalimab (an anti-PD-1 antibody) combined with albumin-bound paclitaxel plus carboplatin. The main questions are: Can this SBRT-immuno-chemo triplet raise the pathologic complete response (pCR; no invasive cancer in breast or nodes at surgery)? Can it produce an objective radiologic response (ORR) in at least half of the patients, allowing more breast-conserving operations and fewer mastectomies? Secondary objectives include safety, changes in tumor-infiltrating lymphocytes (TILs), event-free survival, and exploratory biomarkers (whole-exome and RNA-seq, PBMC immunoprofiling) to discover signatures of benefit. Participants will undergo image-guided core biopsies before and after SBRT, provide serial blood samples, and have definitive surgery 3-5 weeks after the last cycle.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding immunotherapy (toripalimab, which activates the immune system) and targeted radiation (SBRT—high-precision, high-dose radiation to specific tumors) can help women with triple-negative breast cancer whose tumors did not shrink enough after initial standard chemotherapy before surgery. Triple-negative breast cancer is a harder-to-treat type that does not respond to hormone-based treatments. **You may be eligible if...** - You are a woman between 18 and 75 years old with newly diagnosed triple-negative breast cancer - Your cancer is stage II or III - You completed 2 cycles of standard chemotherapy (taxane-based) but your tumor did not shrink (stable or growing on imaging) - You are in good physical condition (ECOG 0–1) - Your organ function is adequate and you do not have HIV or active hepatitis **You may NOT be eligible if...** - You have inflammatory breast cancer - You have had another cancer requiring treatment in the past 3 years - You have an active autoimmune disease or are on high-dose steroids - You have serious heart disease - You have had prior radiation to the breast or chest - You are pregnant or breastfeeding 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

24 Gy in 3 daily fractions (8 Gy each) to the breast primary tumor, started within 1 week after confirmation of chemotherapy resistance.

DRUGToripalimab (anti-PD-1 antibody)

240 mg intravenous infusion every 21 days for 4 cycles

DRUGChemotherapy switch

Albumin-bound paclitaxel 125 mg/m² (days 1 \& 8) plus carboplatin AUC 6 (day 1)


Locations(1)

The Department of Radiation Oncology,the Second Affiliated Hospital of Zhejiang University School of Medicine, hangzhou, zhejiang

Hangzhou, China

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NCT07457359


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