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New study aims to spare thousands of breast cancer patients from unnecessary chemo

NCT ID NCT07379918

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is looking at a genomic test called EndoPredict that analyzes tumor genes to predict the risk of breast cancer returning. The goal is to see if women with a low-risk score can safely skip chemotherapy and only take hormone therapy. Researchers will follow 1,000 patients for 10 years to track relapse and survival rates.

What this could mean

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

Active substance
EndoPredict genomic test
What this could lead to
If successful, this could help doctors safely skip chemotherapy for many women with early breast cancer, reducing side effects without increasing relapse risk.
What could go wrong
This is an observational study, not a treatment trial. It will gather real-world data but won't directly prove that skipping chemotherapy is safe for all patients.

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 1,000 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 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.

Who is studied

All patients included in the SiMoSein prospective database between 2016 and 2021. That is, patients with luminal subtype breast cancer \[RE+/HER2-, N+ or N-), at an early stage of the disease, for whom uncertainty remains regarding the decision to administer adjuvant chemotherapy, according to standard clinical-pathological criteria, and for whom an Endopredict genomic signature has been recommended, performed, and interpreted. The study focuses on cancer centers affiliated with UNICANCER and APHP.

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: * Patient with early breast cancer, hormone receptor-positive, HER2 non-amplified, for whom clinical criteria are deemed insufficient to determine the need for adjuvant chemotherapy, combined with hormone therapy, after breast surgery. Exclusion Criteria: * Patients who did not undergo testing or whose test results were not validated

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Her2-receptor negative 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 breast cancer) Breast cancer prognostic Breast cancer survivors Early hormone receptor-positive (HR-positive) HER2-negative 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

  • Hôpital Saint-Louis

    RECRUITING

    Paris, France

More trials for these conditions

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