Neoadjuvant Toripalimab Plus SBRT for Chemo-Resistant Triple-Negative Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobieta w wieku 18-75 lat z nowo rozpoznanym rakiem piersi
- •Potwierdzony typ nowotworu: brak receptorów hormonalnych i receptora HER2
- •Zaawansowana choroba (stadium II-III)
- •Przebyta chemioterapia (2 cykle), bez poprawy lub pogorszenie stanu
- •Dobry ogólny stan zdrowia (ECOG 0-1)
- •Zgodność lekarza radioterapeuty do leczenia promieniami
- •Prawidłowe wyniki badań krwi i funkcji narządów
- •Ujemne testy na HIV i zapalenie wątroby
✗ Disqualifies
- •Rak piersi zapalny
- •Inne nowotwory wymagające leczenia w ciągu ostatnich 3 lat
- •Aktywna choroba autoimmunologiczna lub przyjmowanie wysokich dawek sterydów
- •Poważne problemy sercowe
- •Poprzednia radioterapia piersi lub ściany klatki piersiowej
- •Aktywna infekcja wymagająca leków
- •Uczulenie na leki badania (toripalimab, paclitaxel, carboplatin)
- •Ciąża lub karmienie piersią
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- March 9, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
The Department of Radiation Oncology，the Second Affiliated Hospital of Zhejiang University School of Medicine, hangzhou, zhejiang
Hangzhou, China
Trial contact
Ting Zhang, phD.
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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