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Could a simple machine take the sting out of breast cancer injections?

NCT ID NCT07533526

Symptom relief Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two ways of giving a large-volume subcutaneous injection of targeted therapy (pertuzumab and trastuzumab) to 40 women with HER2-positive breast cancer. Each patient will receive one injection by a nurse using a stopwatch to mimic a steady speed, and another injection by a medical pump that delivers the drug at a constant rate. The goal is to see which method causes less pain, with the hope that machine-driven injections could improve the treatment experience.

What this could mean

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

Active substance
pertuzumab and trastuzumab (Phesgo) given via subcutaneous injection
What this could lead to
If successful, this could show that using a machine for slow, steady injections reduces pain and improves comfort for breast cancer patients.
What could go wrong
This is a small, early-stage study with only 40 patients, so results may not apply to everyone. The manual injection is timed to match the machine, so any difference in pain might be small.

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 40 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Oct 2026

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 breast cancer patients histologically confirmed as HER2-positive. 2. Have completed at least one subcutaneous injection of Phesgo, with at least three planned injections remaining. 3. No history of acute allergic reactions (e.g., Grade 1-2 allergic reactions) during previous Phesgo injections. 4. Aged between 18 and 70 years (inclusive). 5. No use of pain medications, pain patches, or pain pumps for pain management within 3 days prior to injection. 6. Normal activity level (ECOG score 0-2), no limb paralysis, and able to clearly express personal feelings. 7. Signed informed consent form and voluntarily agreed to participate in this study. Exclusion Criteria: 1. Presence of any skin diseases or conditions affecting subcutaneous injection (e.g., severe infection or dermatitis at the injection site). 2. Simultaneous participation in other clinical trials that may interfere with the results of this study. 3. Cognitive impairment or mental illness preventing completion of study questionnaires and assessments. 4. Regular use of analgesics.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma Pain

As listed by the trial registrant

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

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

  • Medical Ethics Committee of Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510000, China

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