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)

ConditionER+/HER2- Breast Cancer

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexFemale

Age18-75

SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

140 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Source ClinicalTrials.gov