Pilot Study on the Clinical Efficacy of Focused Ultrasound-Mediated Targeted Drug Delivery System… (NCT07616440) | Clinical Trial Compass
RecruitingNot Applicable
Pilot Study on the Clinical Efficacy of Focused Ultrasound-Mediated Targeted Drug Delivery System Combined With Neoadjuvant Therapy for HER2-Positive Breast Cancer
China20 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pathological Complete Response rate
Timeframe: 18 weeks from the enrollment, after the surgey
2
Tumor Pathological Complete Response
Timeframe: 18 weeks from the enllorment, after the surgey
Trial details
NCT IDNCT07616440
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
. No psychological, family, social, or geographical conditions that would compromise compliance with the study protocol and follow-up schedule.
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®.