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Gene test may predict dangerous side effects in breast cancer treatment

NCT ID NCT07582887

Knowledge-focused Sponsor: Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 explores whether certain gene variants (UGT1A1) increase the risk of severe side effects from powerful breast cancer drugs called antibody-drug conjugates. Researchers will enroll 70 adults with advanced breast cancer who are starting treatment with sacituzumab-govitecan, trastuzumab-deruxtecan, or datopotamab-deruxtecan. By analyzing participants' genes and tracking their side effects, the study aims to develop a way to predict who is most at risk, potentially leading to safer, more personalized treatment.

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 70 people

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

Started

Jul 2025

Expected to finish

Mar 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 early, locally advanced, or metastatic breast cancer treated with antibody-drug conjugates in a real-world clinical setting at a single tertiary hospital.

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 aged 18 years or older. * Patients diagnosed with breast cancer starting or undergoing treatment with Sacituzumab Govitecan, Trastuzumab Deruxtecan, or Datopotamab Deruxtecan. * Provision of signed informed consent for the genetic study. Exclusion Criteria: * Patients who are ultimately not treated with the specified Antibody-Drug Conjugates. * Refusal to provide informed consent for genetic analysis.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Drug-Related Side Effects and Adverse Reactions

As listed by the trial registrant

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

Breast cancer Drug-related side effects and adverse reactions Metastatic breast cancer Pharmacogenetic variant

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

  • Hospital Universitario Clínico San Cecilio

    RECRUITING

    Granada, Granada, 18016, Spain

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