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HIFU Combined With Toripalimab and Chemotherapy as Neoadjuvant Therapy for ER+/HER2- Breast Cancer
NCT06964906Phase 2
Key facts
- Status
- Recruiting
- Start
- Mar 2025
- Primary completion
- Dec 2027
- Countries
- 1
- Sponsor
- Second Affiliated Hospital of Zhejiang University School of Medicine
- Modality
- Immune Checkpoint Inhibitors, Recombinant Proteins and Enzymes
- Drugs
- toripalimab
- Conditions
- breast cancer
01
Overview
Phase 2, open-label, single-arm trial of toripalimab in breast cancer, sponsored by Second Affiliated Hospital of Zhejiang University School of Medicine. Primary endpoint: Total Pathological Complete Response Rate at 30 weeks. Started Mar 2025; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
HIFU/Toripalimab + nab-P/Toripalimab + EC
Participants receive HIFU treatment, followed by toripalimab + nab-Paclitaxel for 4 cycles, followed by toripalimab + epirubicin + cyclophosphamide for 4 cycles.
03
Who it enrols
Female patients aged 18-75 with ER+/HER2- invasive breast cancer (T1c-T4, cN0-cN3, Grade 3, PR < 20% or Ki67 >= 20%) without distant metastasis, ECOG 0-1. Excludes pregnant/lactating women, bilateral/occult breast cancer, active autoimmune disease, HIV/HBV/HCV, prior anti-PD-1/L1/L2 therapy, and recent invasive malignancies.
04
Endpoints
Primary
Total Pathological Complete Response Rate
Secondary
Breast Pathological Complete Response Rate
Objective Response Rate
Event-Free Survival
Adverse Events
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