OncoMatch/Clinical Trials/NCT07457359
Neoadjuvant Toripalimab Plus SBRT for Chemo-Resistant Triple-Negative Breast Cancer
Is NCT07457359 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Toripalimab (anti-PD-1 antibody) and Chemotherapy switch for tnbc, triple negative breast cancer.
Treatment: Toripalimab (anti-PD-1 antibody) · Chemotherapy switch — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression < 1% by IHC (< 1%)
ER < 1 % by IHC
Required: PR (PGR) expression < 1% by IHC (< 1%)
PR < 1 % by IHC
Required: HER2 (ERBB2) negative (IHC 0/1+ or IHC 2+ with ISH negative) (IHC 0/1+ or IHC 2+ with ISH negative)
HER2 negative (IHC 0/1+ or IHC 2+ with ISH negative)
Disease stage
Required: Stage II, III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: neoadjuvant chemotherapy (taxane, anthracycline, platinum) — neoadjuvant
Completed 2 cycles of standard neoadjuvant chemotherapy (taxane ± anthracycline ± platinum) and assessed as non-responder: stable disease (SD) or progressive disease (PD) by RECIST 1.1
Cannot have received: radiation therapy
Prior radiotherapy to the breast or chest wall
Lab requirements
Blood counts
wbc ≥ 2 000/µl, anc ≥ 1 500/µl, platelets ≥ 100 000/µl, hb ≥ 9 g/dl
Kidney function
serum creatinine ≤ 2 mg/dl or gfr ≥ 40 ml/min
Liver function
ast/alt ≤ 2.5 × uln, total bilirubin ≤ uln (≤ 3 mg/dl if gilbert syndrome)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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