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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT07616440
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jun 1, 2026
Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Focused Ultrasound Combined with Neoadjuvant Therapy

Primary Outcome Measure

Pathological Complete Response rate [ Time Frame: 18 weeks from the enrollment, after the surgey ]

Central Contacts

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