Pilot Study on the Clinical Efficacy of Focused Ultrasound-Mediated Targeted Drug Delivery System Combined With Neoadjuvant Therapy for HER2-Positive Breast Cancer

This study aimed to evaluate the feasibility and safety, and to observe early efficacy signals of the focused ultrasound mediated drug delivery system combined with SonoVue® in patients with HER2-positive breast cancer receiving neoadjuvant therapy by comparing its pathological complete response (pCR) rate with a matched historical cohort of HER2-positive breast cancer patients treated at our center.

Study Overview

• Status: Not yet recruiting
• Conditions: HER2-positive Breast Cancer
• Intervention / Treatment: Device: Focused Ultrasound-Mediated Targeted Drug Delivery Combined with Neoadjuvant Therapy

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yong Shen; Phone Number: +86-13616555799; Email: shenyong@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female patients aged 18-70 years.
2. Histologically confirmed HER2 positive breast cancer, with indication for neoadjuvant chemotherapy, and scheduled to receive the T(P)CbHP neoadjuvant regimen.
3. TNM stage T2N0-2M0.
4. Adequate bone marrow reserve (ANC >1.5×10⁹/L, platelets >100×10⁹/L).
5. Normal liver function (ALAT, ASAT, and bilirubin <2.5× upper limit of normal).
6. Adequate renal function (creatinine clearance >50 mL/min).
7. Left ventricular ejection fraction (LVEF) ≥50% measured by echocardiography or MUGA.
8. No psychological, family, social, or geographical conditions that would compromise compliance with the study protocol and follow-up schedule.
9. No medical conditions that would place the subject at undue risk.
10. Written informed consent signed by the subject.

Exclusion Criteria:

1. Prior history of radiotherapy or chemotherapy.
2. Pregnant or lactating patients.
3. Presence of distant metastasis.
4. Bilateral invasive breast cancer.
5. Concurrent administration of other anticancer therapies or another investigational agent.
6. inadequate physical tolerance, including significant cardiovascular, hepatic, or renal dysfunction, massive ascites, intestinal obstruction, severe infection, high fever, as well as water-electrolyte and acid-base imbalance.
7. Patients with known hyper sensitivity to SonoVue®.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Focused Ultrasound Combined with Neoadjuvant Therapy

Device: Focused Ultrasound-Mediated Targeted Drug Delivery Combined with Neoadjuvant Therapy; Participants will undergo six cycles of focused ultrasound-mediated targeted drug delivery combined with neoadjuvant therapy. The ultrasound parameters are set as follows: ultrasound power 9 W (acoustic pressure 3 MPa), frequency 1 MHz, pulse duration 100 μs, pulse repetition frequency 100 Hz, with 5 treatment cycles per single point. During each treatment session, 2.5 mL of SonoVue® ultrasound contrast agent microbubbles is injected via the cubital vein, followed by a 5 mL normal saline flush. Subsequently, 2.5 mL of SonoVue® microbubbles are administered every 2 minutes, with a total injection volume of 15 mL throughout the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pathological Complete Response rate	18 weeks from the enrollment, after the surgey
Tumor Pathological Complete Response	18 weeks from the enllorment, after the surgey

Secondary Outcome Measures

Outcome Measure	Time Frame
Event-Free Survival (EFS)	3 years after the surgery

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Yiding Chen, The Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU)

Study record dates

Study Major Dates

• Study Start (Estimated): May 29, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: May 24, 2026
• First Submitted That Met QC Criteria: May 24, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 24, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Combined Modality Therapy; Neoadjuvant Therapy
• Other Study ID Numbers: 2026-0368

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No