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Can less chemo be enough? a trial challenges standard treatment for HER2-Positive breast cancer

NCT ID NCT07748260

Disease control Sponsor: Guangdong Provincial People's Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether giving four cycles of chemotherapy combined with targeted therapy (trastuzumab and pertuzumab) before surgery works as well as the standard six cycles for people with intermediate-risk HER2-positive breast cancer. The goal is to see if a shorter treatment can reduce side effects without compromising the chance of eliminating the tumor. The study will compare the rates of complete tumor disappearance between the two treatment groups.

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 chemotherapy (taxane) plus two targeted antibodies, trastuzumab and pertuzumab, given for either 4 or 6 cycles before surgery.
What this could lead to
If successful, this could show that many patients with intermediate-risk HER2-positive breast cancer can receive fewer chemotherapy cycles, reducing side effects while maintaining treatment effectiveness.
What could go wrong
The trial is still in progress, and it is not yet known if the shorter treatment will be as effective as the longer one. There is also a risk that reducing chemotherapy could lead to higher rates of residual cancer.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 592 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2031

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 years and older

Sex

Anyone

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: Histopathologically confirmed HER2-positive invasive breast cancer; Clinical staging of disease classified as T2N0M0. Exclusion Criteria: Patients who have undergone chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for this condition; Due to severe and uncontrolled medical conditions, the investigator deems chemotherapy contraindicated.

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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 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.