Recruiting

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.

ClinicalTrials.gov IDNCT07616440

PhaseNA

Enrollment20

SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

HER2-positive Breast Cancer

About this study

Interventions

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.

Primary outcomes

Pathological Complete Response rate (18 weeks from the enrollment, after the surgey)
Tumor Pathological Complete Response (18 weeks from the enllorment, after the surgey)

Eligibility information

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 locations

The Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU), Hangzhou, Zhejiang 310000 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.