HER2-positive Breast Cancer
Conditions
Brief 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.
Interventions
DEVICEFocused 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. Subsequently, 2.5 mL of SonoVue® microbubbles are administered every 2 minutes, with a total injection volume of 15 mL throughout the procedure.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Female patients aged 18-70 years. 2. Histologically confirmed HER2 positive breast cancer, with indication for neoadjuvant chemotherapy, and scheduled to receive the T(P)CbHP neoadjuvant regimen. 3. TNM stage T2N0-2M0. 4. Adequate bone marrow reserve (ANC \>1.5×10⁹/L, platelets \>100×10⁹/L). 5. Normal liver function (ALAT, ASAT, and bilirubin \<2.5× upper limit of normal). 6. Adequate renal function (creatinine clearance \>50 mL/min). 7. Left ventricular ejection fraction (LVEF) ≥50% measured by echocardiography or MUGA. 8. No psychological, family, social, or geographical conditions that would compromise compliance with the study protocol and follow-up schedule. 9. No medical conditions that would place the subject at undue risk. 10. Written informed consent signed by the subject.
Exclusion criteria
1. Prior history of radiotherapy or chemotherapy. 2. Pregnant or lactating patients. 3. Presence of distant metastasis. 4. Bilateral invasive breast cancer. 5. Concurrent administration of other anticancer therapies or another investigational agent. 6. 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. 7. Patients with known hyper sensitivity to SonoVue®.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response rate | 18 weeks from the enrollment, after the surgey |
| Tumor Pathological Complete Response | 18 weeks from the enllorment, after the surgey |
Secondary
| Measure | Time frame |
|---|---|
| Event-Free Survival (EFS) | 3 years after the surgery |
Countries
China
Contacts
CONTACTYong Shen
PRINCIPAL_INVESTIGATORYiding Chen
The Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU)
Outcome results
None listed