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

NCT07616440 | Recruiting

• 1 other identifier: 2026-0368
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Event-Free Survival (EFS)

  3 years after the surgery

Study Arms (1)

Focused Ultrasound Combined with Neoadjuvant Therapy

EXPERIMENTAL

Device: Focused Ultrasound-Mediated Targeted Drug Delivery Combined with Neoadjuvant Therapy

Interventions

Focused Ultrasound-Mediated Targeted Drug Delivery Combined with Neoadjuvant Therapy DEVICE

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.

Focused Ultrasound Combined with Neoadjuvant Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Prior history of radiotherapy or chemotherapy.
• Pregnant or lactating patients.
• Presence of distant metastasis.
• Bilateral invasive breast cancer.
• Concurrent administration of other anticancer therapies or another investigational agent.
• 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.
• Patients with known hyper sensitivity to SonoVue®.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU)

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Interventions

Neoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Yiding Chen

  The Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Shen

CONTACT

+86-13616555799; shenyong@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 1, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)