Pilot Study on the Clinical Efficacy of Focused Ultrasound-Mediated Targeted Drug Delivery System Combined With Neoadjuvant Therapy for HER2-Positive Breast Cancer
Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Not applicable
Started
2026-06-01
Last updated
2026-06-04
Condition(s) studied
HER2-positive Breast Cancer
Investigational drug(s) / intervention(s)
Focused Ultrasound-Mediated Targeted Drug Delivery Combined with Neoadjuvant Therapy
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.
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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®.
Primary outcome measure(s)
Pathological Complete Response rate — 18 weeks from the enrollment, after the surgey
Tumor Pathological Complete Response — 18 weeks from the enllorment, after the surgey
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU)
Hangzhou
Zhejiang
Recruiting
More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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