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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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 criteria

Qualifiers

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).

Disqualifiers

Prior history of radiotherapy or chemotherapy.

Pregnant or lactating patients.

Presence of distant metastasis.

Bilateral invasive breast cancer.

Trial design

Treatments tested in this trial

  • Focused Ultrasound-Mediated Targeted Drug Delivery Combined with Neoadjuvant Therapy

Treatment groups

20 Participants
are divided into 1 treatment group