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Genetic test may help some breast cancer patients avoid unnecessary chemo

NCT ID NCT03961880

Knowledge-focused Sponsor: University Hospital Tuebingen 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This study looked at 270 women with early-stage, hormone-receptor-positive, HER2-negative breast cancer. Doctors used a genetic test called OncotypeDX to estimate each patient's risk of the cancer coming back. The goal was to see how the test results influenced whether patients received chemotherapy. The study also checked for cancer cells in the bone marrow to see if there was a link with the genetic risk score.

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

270 people

The number who actually took part.

Started

Mar 2019

Finished

Jun 2025

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

Women with breast cancer

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * women ≥ 18 years of age * histologically proven unilateral primary non-metastatic invasive breast cancer * ER-/ or PR- positive and HER2-negative * N0-N1 (0-3 involved lymph-nodes). The nodal status may be evaluated clinically. * surgery or planed surgery at the Department of women's health, Tuebingen * written informed consent into IRMA Exclusion Criteria: * ER-negative * HER2-positive * \> 3 involved lymph-nodes * bilateral breast cancer * preexisting cancer disease within the last 10 years * preexisting invasive ipsi- or contralateral breast cancer (non-invasive ipsi- or contralateral breast cancer is not regarded as an exclusion criteria) * primary systemic therapy * locally advanced, inoperable or metastatic breast cancer * pregnant or lactating patients * inadequate general condition (not fit for chemotherapy)

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Conditions

The condition(s) this trial relates to.

breast cancer female breast carcinoma

As listed by the trial registrant

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

Breast cancer female

Contacts and locations

Locations

  • Department for Women's Health

    Tübingen, Baden-Wurttemberg, 72086, Germany

More trials for these conditions

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