Study of High-Intensity Focused Ultrasound (HIFU) Combined With Toripalimab Plus Chemotherapy Versus Chemotherapy as Neoadjuvant Therapy for Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (NeoHunter)

NCT06964906 | Recruiting Phase 2 DMC

• 1 other identifier: 2024-0367
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of high-intensity focused ultrasound (HIFU) combined with toripalimab plus chemotherapy versus chemotherapy as neoadjuvant therapy for ER+/HER2- breast cancer.

Conditions

ER+/HER2- Breast Cancer

Keywords

Breast Neoplasms; High-intensity focused ultrasound; PD1; Toripalimab; nab-Paclitaxel; Epirubicin; Cyclophosphamide

Outcome Measures

Primary Outcomes (1)

• Total Pathological Complete Response (tpCR) Rate: ypT0/Tis, ypN0

  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.

  Up to approximately 30 weeks

Secondary Outcomes (4)

• Breast Pathological Complete Response (bpCR) Rate: ypT0/Tis

  Up to approximately 30 weeks

• Objective Response Rate (ORR)

  Up to approximately 30 weeks

• Event-Free Survival (EFS)

  Approximately five years

• Adverse Event (AE)

  Approximately three years

Study Arms (2)

HIFU/Toripalimab + nab-P/Toripalimab + EC

EXPERIMENTAL

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.

Procedure: HIFU; Drug: Toripalimab; Drug: nab-Paclitaxel (nab-P); Drug: Epirubicin (E); Drug: Cyclophosphamide (C)

nab-P/EC

ACTIVE COMPARATOR

Participants receive nab-Paclitaxel (QW) for 4 cycles (12 weeks), followed by epirubicin (Q3W) + cyclophosphamide (Q3W) for 4 cycles (12 weeks). Each cycle lasts 21 days.

Drug: nab-Paclitaxel (nab-P); Drug: Epirubicin (E); Drug: Cyclophosphamide (C)

Interventions

HIFU PROCEDURE

HIFU therapy is administered to the targeted breast lesion site.

HIFU/Toripalimab + nab-P/Toripalimab + EC

Toripalimab DRUG

240 mg, IV infusion, Q3W

HIFU/Toripalimab + nab-P/Toripalimab + EC

nab-Paclitaxel (nab-P) DRUG

125 mg/m2, IV infusion, QW

HIFU/Toripalimab + nab-P/Toripalimab + EC; nab-P/EC

Epirubicin (E) DRUG

90 mg/m2, IV infusion, Q3W

HIFU/Toripalimab + nab-P/Toripalimab + EC; nab-P/EC

Cyclophosphamide (C) DRUG

600 mg/m2, IV infusion, Q3W

HIFU/Toripalimab + nab-P/Toripalimab + EC; nab-P/EC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 18-75 years.
• Invasive breast cancer without distant metastasis, including either T1c-T2 (≥ 2 cm), cN1-cN2, or T3-T4, cN0-cN2.
• Histopathologically confirmed ER-positive/HER2-negative, PR \< 20% or Ki67 ≥ 20%, Grade 3 breast cancer.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

You may not qualify if:

• Female patients during pregnancy or lactation.
• Diagnosis of bilateral breast cancer, occult breast cancer, or distant metastasis confirmed by pathology.
• Has an active autoimmune disease that has received systemic treatment in the last 2 years.
• Has a known history of human immunodeficiency virus (HIV), hepatitis B, or known active hepatitis C virus infection.
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
• Has a known history of invasive malignancy that required systemic treatment in the last 5 years.
• Uncontrolled concomitant diseases include severe infection, liver disease, cardiovascular disease, kidney disease, respiratory disease, diabetes, and others requiring systemic treatment.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

toripalimab; 130-nm albumin-bound paclitaxel; Epirubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Yiding Chen

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yiding Chen

CONTACT

+86 0571 87783759; ydchen@zju.edu.cn

Shijie Wu

CONTACT

shijiewu@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 11, 2025
• Study Start: March 4, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (1)