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Can a simple ratio predict breast cancer treatment success?

NCT ID NCT07376174

Knowledge-focused Sponsor: Shandong Cancer Hospital and Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a very high level of a protein called HER2 (measured by the HER2/CEP17 ratio) affects how well breast cancer patients do after treatment with a combination of two targeted drugs (trastuzumab and pertuzumab). Researchers will review medical records of 300 adults with early-stage HER2-positive breast cancer who had surgery and this dual therapy. The goal is to see if those with ultra-high HER2 levels have different outcomes, like time until cancer returns.

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.

Participants

About 300 people

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

Started

Jan 2026

Expected to finish

Jun 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.

Who is studied

HER2-positive patients with breast cancer were enrolled between January 2020 and December 2023.

Ages

18 years and older

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. Age ≥18 years. 2. Pathologically confirmed primary breast cancer, clinical stage I-III (AJCC 8th Edition). 3. HER2-positive status confirmed by FISH testing (per ASCO/CAP guidelines) with available HER2/CEP17 ratio. 4. Received at least one dose of dual-target therapy (trastuzumab combined with pertuzumab) in the adjuvant or neoadjuvant setting. 5. Underwent curative-intent surgery (mastectomy or breast-conserving surgery). Exclusion Criteria: 1. Presence of distant metastasis (Stage IV) or contralateral breast cancer at initial diagnosis. 2. Previous anti-HER2 targeted therapy prior to dual-target treatment. 3. Missing key clinical data (e.g., HER2 FISH results, treatment regimen, surgery date). 4. Carcinoma in situ or occult breast cancer, non-primary breast cancer, or concurrent other malignancies. 5. Loss to follow-up or follow-up duration \<3 months (unless recurrence or death occurred within this period).

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

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

Breast cancer HER2/CEP17 ratio

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

  • Department of Medical Oncology

    RECRUITING

    Jinan, Shandong, China

More trials for these conditions

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