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)

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.

Trial Details

NCT ID

NCT06964906

Phase

PHASE2

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

RECRUITING

Cancer Type

HER2 Positive Breast Cancer

Interventions

HIFU
Toripalimab
nab-Paclitaxel (nab-P)
Epirubicin (E)
Cyclophosphamide (C)

Locations (sample)

Hangzhou, Zhejiang, China|30.29365,120.16142

Key Eligibility Criteria

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.

For full eligibility, visit ClinicalTrials.gov.

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