Clinical trial · Interventional
Neoadjuvant High-Intensity Focused Ultrasound (HIFU) Combined With Toripalimab and Chemotherapy for ER-Positive /HER2-Negative Breast Cancer
A Prospective, Single-arm Study of High-Intensity Focused Ultrasound (HIFU) Combined With Toripalimab and Chemotherapy as Neoadjuvant Therapy for Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (NeoHunter)
NCT06964906CI-TRIAL-00117831NeoHunterrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to evaluate the efficacy and safety of high-intensity focused ultrasound (HIFU) combined with toripalimab and chemotherapy as neoadjuvant therapy for ER+/HER2- breast cancer.
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 |
|---|---|---|---|
| ER+/HER2- Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide (C) | Drug | Cyclophosphamide | ALIAS |
| Epirubicin (E) | Drug | Epirubicin | ALIAS |
| HIFU | Procedure | — | UNRESOLVED |
| nab-Paclitaxel (nab-P) | Drug | Nab-paclitaxel | ALIAS |
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HIFU/Toripalimab + nab-P/Toripalimab + EC
- description
- Participants receive HIFU treatment, followed by toripalimab (Q3W) + nab-Paclitaxel (QW) for 4 cycles (12 weeks), followed by toripalimab (Q3W) + epirubicin (Q3W) + cyclophosphamide (Q3W) for 4 cycles (12 weeks). Each cycle lasts 21 days.
- interventionNames
- Procedure: HIFU
- Drug: Toripalimab
- Drug: nab-Paclitaxel (nab-P)
- Drug: Epirubicin (E)
- Drug: Cyclophosphamide (C)
Primary outcomes (1)
- measure
- Total Pathological Complete Response (tpCR) Rate: ypT0/Tis, ypN0
- timeFrame
- Up to approximately 30 weeks
- description
- The tpCR rate is defined as the proportion of participants with no residual invasive cancer cells in both the breast primary tumor site (residual in situ cancer cells are permitted) and all sampled axillary lymph nodes.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patients aged 18-75 years. 2. Invasive breast cancer without distant metastasis, including either T1c-T4 (≥ 2 cm), cN0-cN3. 3. Histopathologically confirmed ER-positive/HER2-negative, PR \< 20% or Ki67 ≥ 20%, Grade 3 breast cancer. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Exclusion Criteria: 1. Female patients during pregnancy or lactation. 2. Diagnosis of bilateral breast cancer, occult breast cancer, or distant metastasis confirmed by pathology. 3. Has an active autoimmune disease that has received systemic treatment in the last 2 years. 4. Has a known history of human immunodeficiency virus (HIV), hepatitis B, or known active hepatitis C virus infection. 5. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. 6. Has a known history of invasive malignancy that required systemic treatment in the last 5 years. 7. Uncontrolled concomitant diseases include severe infection, liver disease, cardiovascular disease, kidney disease, respiratory disease, diabetes, and others requiring systemic treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.