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

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

Trial Details

NCT ID

NCT07457359

Phase

PHASE2

Sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Status

RECRUITING

Cancer Type

Breast Cancer

Interventions

SBRT
Toripalimab (anti-PD-1 antibody)
Chemotherapy switch

Locations (sample)

Hangzhou, China|30.29365,120.16142

Key Eligibility Criteria

Female, age 18-75 years, newly diagnosed invasive breast cancer.
Histologically confirmed triple-negative phenotype: ER \< 1 %, PR \< 1 % by IHC, HER2 negative (IHC 0/1+ or IHC 2+ with ISH negative).
Clinical stage II-III (T2-4 or N1-3, M0).
Completed 2 cycles of standard neoadjuvant chemotherapy (taxane ± anthracycline ± platinum) and assessed as non-responder: stable disease (SD) or p…

For full eligibility, visit ClinicalTrials.gov.

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