HER2-positive Breast CancerNCT07616440
Pilot Study on the Clinical Efficacy of Focused Ultrasound-Mediated Targeted Drug Delivery System Combined With Neoadjuvant Therapy for HER2-Positive Breast Cancer
A study testing Focused Ultrasound-Mediated Targeted Drug Delivery Combined with Neoadjuvant Therapy in people with HER2-positive Breast Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- Focused Ultrasound-Mediated Targeted Drug Delivery Combined with Neoadjuvant Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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®.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU)
Hangzhou, Zhejiang, 310000
Yong Shen, +86-13616555799, shenyong@zju.edu.cn
About this study
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.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- Focused Ultrasound-Mediated Targeted Drug Delivery Combined with Neoadjuvant Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused Ultrasound-Mediated Targeted Drug Delivery Combined with Neoadjuvant TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Focused Ultrasound Combined with Neoadjuvant Therapy | Experimental | Not described Receives: Device: Focused Ultrasound-Mediated Targeted Drug Delivery Combined with Neoadjuvant Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response rate
Measured: 18 weeks from the enrollment, after the surgey
Tumor Pathological Complete Response
Measured: 18 weeks from the enllorment, after the surgey
Secondary outcomes (1)
Event-Free Survival (EFS)
Measured: 3 years after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Jun 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yiding Chen, Principal investigator, The Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616440
- Sponsor's protocol ID
- 2026-0368
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Clinical Efficacy of Focused Ultrasound-Mediated Targeted Drug Delivery System Combined With Neoadjuvant Therapy for HER2-Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT07616440
- Acronym / sponsor ID
- 2026-0368
- Conditions
- HER2-positive Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focused Ultrasound Combined with Neoadjuvant Therapy | Experimental | Device: Focused Ultrasound-Mediated Targeted Drug Delivery Combined with Neoadjuvant Therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused Ultrasound-Mediated Targeted Drug Delivery Combined with Neoadjuvant TherapyParticipants 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. | Device | Focused Ultrasound Combined with Neoadjuvant Therapy |
Primary outcome
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
1 secondary outcome
Event-Free Survival (EFS)
Time frame: 3 years after the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yiding Chen principal investigator
The Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused Ultrasound-Mediated Targeted Drug Delivery Combined with Neoadjuvant Therapy in people with HER2-positive Breast Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Shen (+86-13616555799, shenyong@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response rate (time frame: 18 weeks from the enrollment, after the surgey). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.