OncoMatch/Clinical Trials/NCT06964906
Neoadjuvant High-Intensity Focused Ultrasound (HIFU) Combined With Toripalimab and Chemotherapy for ER-Positive /HER2-Negative Breast Cancer
Is NCT06964906 recruiting? Yes, currently enrolling (Sep 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 and 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 expression (positive)
ER-positive
Required: HER2 (ERBB2) wild-type (negative)
HER2-negative
Required: PR (PGR) expression (< 20%)
PR < 20%
Required: MKI67 expression (≥ 20%)
Ki67 ≥ 20%
Disease stage
Grade: 3
Performance status
ECOG 0–1(Restricted strenuous activity)
ECOG performance status of 0-1
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.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression is a required biomarker for enrollment.
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 qualify