Impact of Genetic Variants on the Toxicity of Antibody-Drug Conjugates in Locally Advanced or Metastatic Breast Cancer: The Role of the UGT1A1 Gene as a Predictive Biomarker of Therapeutic Response

Plain-language summary

This study looks at how genetic variants, especially in the UGT1A1 gene, affect the toxicity of antibody-drug conjugates used in locally advanced or metastatic breast cancer. It focuses on patients treated with Sacituzumab Govitecan, Trastuzumab deruxtecan or Datopotamab Deruxtecan, and can include adults aged 18 or older with breast cancer. It is a study without an assigned phase and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

Intervention

Sacituzumab Govitecan, Trastuzumab deruxtecan, Datopotamab Deruxtecan

Start date

7/15/2025

Estimated completion

3/31/2027

Countries

Spain

Related genes

Locations

• Granada, Spain

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.