OncoMatch/Clinical Trials/NCT06964906

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)

Is NCT06964906 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Toripalimab and nab-Paclitaxel (nab-P) for er+/her2- breast cancer.

Phase 2RecruitingSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityNCT06964906Data as of May 2026

Treatment: Toripalimab · nab-Paclitaxel (nab-P) · Epirubicin (E) · Cyclophosphamide (C) — 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.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: ESR1 positive

ER-positive

Required: HER2 (ERBB2) negative

HER2-negative

Allowed: PR (PGR) expression < 20%

PR < 20%

Allowed: KI67 expression ≥ 20%

Ki67 ≥ 20%

Disease stage

Required: Stage T1C-T2 (≥ 2 CM), CN1-CN2, T3-T4, CN0-CN2 (TNM)

Grade: 3

Invasive breast cancer without distant metastasis, including either T1c-T2 (≥ 2 cm), cN1-cN2, or T3-T4, cN0-cN2

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: anti-PD-1/PD-L1/PD-L2 therapy

Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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