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

Inclusion criteria

• 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 criteria

• 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®.