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Sound waves plus immunotherapy: a new attack on breast cancer before surgery

NCT ID NCT06964906

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This trial investigates whether combining high-intensity focused ultrasound (HIFU) with the immunotherapy drug toripalimab and standard chemotherapy can improve outcomes for people with ER+/HER2- breast cancer before they undergo surgery. The study enrolls women aged 18-75 with invasive, non-metastatic breast cancer. The goal is to see if this approach leads to a complete disappearance of cancer in the breast and lymph nodes at the time of surgery.

What this could mean

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

Active substance
a combination of high-intensity focused ultrasound (HIFU), toripalimab, and chemotherapy drugs (nab-paclitaxel, epirubicin, cyclophosphamide)
What this could lead to
If successful, this combination could become a new pre-surgery treatment option for ER+/HER2- breast cancer, potentially increasing the chance of eliminating all cancer before surgery.
What could go wrong
This is a small, early-phase study with only 30 participants, so results may not apply to all patients. The combination may cause significant side effects and may not improve outcomes compared to standard therapy.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

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

Started

Mar 2025

Expected to finish

Dec 2030

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 75 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 18-75 years. 2. Invasive breast cancer without distant metastasis, including either T1c-T4 (≥ 2 cm), cN0-cN3. 3. Histopathologically confirmed ER-positive/HER2-negative, PR \< 20% or Ki67 ≥ 20%, Grade 3 breast cancer. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Exclusion Criteria: 1. Female patients during pregnancy or lactation. 2. Diagnosis of bilateral breast cancer, occult breast cancer, or distant metastasis confirmed by pathology. 3. Has an active autoimmune disease that has received systemic treatment in the last 2 years. 4. Has a known history of human immunodeficiency virus (HIV), hepatitis B, or known active hepatitis C virus infection. 5. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. 6. Has a known history of invasive malignancy that required systemic treatment in the last 5 years. 7. Uncontrolled concomitant diseases include severe infection, liver disease, cardiovascular disease, kidney disease, respiratory disease, diabetes, and others requiring systemic treatment.

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Conditions

The condition(s) this trial relates to.

breast neoplasm estrogen-receptor positive breast cancer

As listed by the trial registrant

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

ER+/HER2- 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

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

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