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 (Jun 2026). This Phase 2 trial studies multiple treatments including Toripalimab and nab-Paclitaxel (nab-P) for er+/her2- breast cancer.
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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06964906 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-PD-1/PD-L1/PD-L2 therapy disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 positive is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
What disease stage is eligible?
Stage T1C-T2 (≥ 2 CM) or CN1-CN2 or T3-T4 or CN0-CN2 is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages