Recruiting NCT07616440
Pilot Study on the Clinical Efficacy of Focused Ultrasound-Mediated Targeted Drug Delivery System Combined With Neoadjuvant Therapy for HER2-Positive Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Focused Ultrasound-Mediated Targeted Drug Delivery Combined with Neoadjuvant Therapy.
- Who it may be relevant to
- Registry conditions: HER2-positive Breast Cancer. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Focused Ultrasound-Mediated Targeted Drug Delivery Combined with Neoadjuvant Therapy
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.
Primary outcome measures
- Pathological Complete Response rate [Time frame: 18 weeks from the enrollment, after the surgey]
- Tumor Pathological Complete Response [Time frame: 18 weeks from the enllorment, after the surgey]
Secondary outcome measures (1)
- Event-Free Survival (EFS) [Time frame: 3 years after the surgery]
Eligibility criteria
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®.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU) — Hangzhou
Identifiers
NCT: NCT07616440 · 2026-0368