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.
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).
Prior history of radiotherapy or chemotherapy.
Pregnant or lactating patients.
Presence of distant metastasis.
Bilateral invasive breast cancer.
Single group
Focused Ultrasound-Mediated Targeted Drug Delivery Combined with Neoadjuvant Therapy
DeviceParticipants 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.
Pathological Complete Response rate
Tumor Pathological Complete Response
Event-Free Survival (EFS)
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