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Gene test may guide breast cancer treatment decisions

NCT ID NCT06723990

Knowledge-focused Sponsor: European Institute of Oncology 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a genetic test called HER2DX can help doctors decide on the best treatment for people with early-stage HER2-positive breast cancer. The study will enroll 60 patients and observe how often the test results change the treatment plan recommended by a team of specialists. The goal is to see if the test improves confidence in treatment choices, not to directly test a new drug.

What this could mean

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

Active substance
HER2DX genetic test
What this could lead to
If successful, this could show that a genetic test helps doctors personalize treatment for HER2+ breast cancer, potentially improving outcomes and reducing unnecessary side effects.
What could go wrong
This is a small, observational study (60 people) at one center. It only measures if doctors change their decisions, not if those changes actually improve patient health. The test may not be widely adopted or beneficial.

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 60 people

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

Started

Oct 2024

Expected to finish

Nov 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.

Who is studied

HER2 positive breast cancer patients with stage I-III

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: * Patients ≥ 18 years of age; * Histologically confirmed HER2+ breast cancer; * Stage I-III breast cancer without evidence of distant metastases; * Being candidate to neoadjuvant/adjuvant therapy and locoregional treatment (surgery +/- radiotherapy); * Written informed consent, signed by the patient, to study-specific procedures (the consent will consist of 2 levels: level 1 specifically for patients enrolled in the primary endpoint cohort and level 2 for all patients); Exclusion Criteria: * HER2- BC; * Stage IV breast cancer; * Lack of informed consent because of patient's incapable of discernment or unwilling to participate;

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Conditions

The condition(s) this trial relates to.

breast cancer HER2 positive breast carcinoma

As listed by the trial registrant

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

Breast cancer early stage breast cancer (stage 1-3)

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

  • Istituto Europeo di Oncologia

    RECRUITING

    Milan, Italy, Italy

More trials for these conditions

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