Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| TNBC, Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy switch | Drug | — | UNRESOLVED |
| SBRT | Radiation | — | UNRESOLVED |
| Toripalimab (anti-PD-1 antibody) | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT-Toripalimab-Chemo Rescue
- description
- All enrolled participants receive the same regimen: 1. Stereotactic Body Radiation Therapy (SBRT): started within 1 week after confirmation of chemotherapy resistance. 2. Toripalimab (anti-PD-1 antibody): cycle 1 starts the day after SBRT ends. 3. Chemotherapy switch: every 21 days for 4 cycles.
- interventionNames
- Radiation: SBRT
- Drug: Toripalimab (anti-PD-1 antibody)
- Drug: Chemotherapy switch
Primary outcomes (1)
- measure
- pCR rate
- timeFrame
- At definitive surgery, 3-5 weeks after completion of cycle 4 (week 15 from study entry)
- description
- Pathological complete response (pCR), percentage of patients with no invasive residual tumor in breast and lymph nodes (ypT0/is ypN0) at surgery.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion 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 progressive disease (PD) by RECIST 1.1. * ECOG performance status 0 or 1. * Radiation oncologist confirms suitability for SBRT and subsequent standard post-operative radiotherapy. * Adequate organ function within 14 days before enrollment: WBC ≥ 2 000/µL, ANC ≥ 1 500/µL, platelets ≥ 100 000/µL, Hb ≥ 9 g/dL; Serum creatinine ≤ 2 mg/dL or GFR ≥ 40 mL/min; AST/ALT ≤ 2.5 × ULN, total bilirubin ≤ ULN (≤ 3 mg/dL if Gilbert syndrome); INR ≤ 1.5 (on anticoagulation allowed if therapeutic range) * Negative HIV, HBV surface antigen, and HCV antibody (or HBV DNA / HCV RNA negative if false-positive). Exclusion Criteria: * Inflammatory breast cancer. * Any other malignancy requiring treatment within the past 3 years (except adequately treated basal-cell skin carcinoma or cervical CIS). * Active autoimmune disease, immunodeficiency, or systemic steroids \> 10 mg/day prednisone equivalent within 2 years. * Clinically significant cardiovascular disease (unstable angina, NYHA III/IV heart failure, recent MI). * Prior radiotherapy to the breast or chest wall. * Active infection requiring systemic therapy. * Known intolerance or hypersensitivity to toripalimab, paclitaxel, or carboplatin. * Pregnant or lactating women.
References
Publications (0)
Data not yet available