OncoMatch/Clinical Trials/NCT07457359
Neoadjuvant Toripalimab Plus SBRT for Chemo-Resistant Triple-Negative Breast Cancer
Is NCT07457359 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT07457359 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radiation therapy disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 expression < 1% by IHC is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression < 1% by IHC is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative (IHC 0/1+ or IHC 2+ with ISH negative) is a required biomarker for enrollment.
What disease stage is eligible?
Stage II or III is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify