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Sound waves could help chemo reach breast tumors

NCT ID NCT07616440

Disease control Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This pilot study tests whether focused ultrasound, combined with tiny gas bubbles (microbubbles), can help chemotherapy drugs penetrate deeper into HER2-positive breast tumors. Twenty women will receive the ultrasound treatment alongside standard neoadjuvant therapy before surgery. The goal is to see if this approach is safe and leads to higher rates of complete tumor disappearance compared to historical data.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SonoVue® ultrasound contrast agent microbubbles
What this could lead to
If it works, this could improve how well chemotherapy reaches tumors, potentially increasing the chance of complete tumor disappearance before surgery.
What could go wrong
This is a very small pilot study (20 people) with no control group, so results may not be reliable. The procedure involves repeated ultrasound sessions and injections, which may cause discomfort or unknown side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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®.

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Conditions

The condition(s) this trial relates to.

HER2 positive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HER2-positive breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU)

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

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