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Gene test may Fine-Tune breast cancer therapy for younger women

NCT ID NCT06807749

Knowledge-focused Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This study looks back at the records of 800 premenopausal women with early-stage, hormone-positive, HER2-negative breast cancer who took the Oncotype DX test between 2013 and 2022. Researchers will compare how different adjuvant treatments affect 5-year invasive disease-free survival based on each woman's genomic risk score. The goal is to see whether the test can better predict who benefits from chemotherapy after surgery.

What this could mean

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

Active substance
Oncotype DX test (21-gene assay) to guide adjuvant treatment decisions
What this could lead to
If successful, this could refine how doctors use the Oncotype DX test to choose adjuvant therapy for premenopausal women with early breast cancer, potentially sparing some from unnecessary chemotherapy.
What could go wrong
This is an observational study, so it cannot prove cause and effect. Results may be affected by treatment choices made outside the study, and the findings may not apply to all patient groups.

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 800 people

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

Started

Dec 2025

Expected to finish

Sep 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

Patients with premenopausal early breast cancer HR+ HER2 negative diagnosis with any Recurrence Score (RS) and pathological nodal status pN0/pN1 and who underwent the 21-multigene assay Oncotype DX from 1st January 2013 to 31st December 2022 and adjuvant treatment.

Ages

Up to 60 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, premenopausal and ≥18 years age patients. 2. Agree to participate in study and signing informed consent or declaration in lieu of informed consent form, if applicable 3. Histological diagnosis of early breast cancer hormone positive (ER and/or PgR), HER2-negative. 4. Pathological nodal stage of pN0 or pN1 (1-3 nodes) and pathological tumor stage of pT1 to pT3. 5. Surgery for primary breast cancer and axillary staging by sentinel node biopsy or axillary lymph node dissection (ALND). 6. Availability of 21-multigene assay Oncotype DX recurrence score results performed according to physician choice from 1st January 2013 to 31st December 2022 7. Availability of clinical and pathological information. 8. Availability of information about adjuvant treatment received. 9. Availability of patient' outcome information (relapse, site of relapse, survival). Exclusion Criteria: 1. Evidence of distant metastases 2. Inflammatory breast cancer 3. Neoadjuvant treatment 4. No surgery for primary breast cancer and axillary staging 5. Patients not tested with 21-multigene assay Oncotype DX

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Conditions

The condition(s) this trial relates to.

breast cancer hormone receptor-positive breast cancer

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

    2 sites. 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

  • Clinical Research Technology

    NOT_YET_RECRUITING

    Salerno, Italy

  • Fondazione Policlinico Gemelli

    RECRUITING

    Roma, Antonella Palazzo, Italy

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