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, School of Medicine, Zhejiang University
20 participants
Jun 1, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria10
- 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.
Exclusion Criteria7
- 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®.
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Interventions
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.
Locations(1)
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NCT07616440