UGT1A1 gene and side effects from certain antibody-drug treatments for advanced breast cancer
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
This project will test whether common UGT1A1 gene variants explain who gets worse side effects from antibody-drug conjugates (sacituzumab-govitecan, trastuzumab-deruxtecan, or datopotamab-deruxtecan) in adults with advanced breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental Academic / other |
| Drugs / interventions | Sacituzumab, Trastuzumab, Datopotamab |
| Locations | 1 site (Granada, Granada) |
| Trial ID | NCT07582887 on ClinicalTrials.gov |
What this trial studies
This observational study collects genetic data and clinical toxicity information from adults with locally advanced or metastatic breast cancer who are starting or receiving specified antibody-drug conjugates. Participants provide informed consent for UGT1A1 genotyping and clinicians record adverse events such as neutropenia and severe diarrhea during treatment. Investigators will correlate UGT1A1 variant status (for example *28 and *6) with the frequency and severity of treatment-related toxicities. The goal is to determine whether UGT1A1 variants predict higher risk of adverse effects across these ADCs.
Who should consider this trial
Good fit: Adults (18+) with breast cancer who are starting or receiving sacituzumab-govitecan, trastuzumab-deruxtecan, or datopotamab-deruxtecan and who agree to genetic testing are eligible.
Not a fit: Patients not receiving the specified antibody-drug conjugates or those who decline genetic testing are unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, the findings could help predict which patients are at higher risk of severe toxicity so clinicians can personalize dosing or choose alternative treatments to reduce harm.
How similar studies have performed: Prior research has linked UGT1A1 variants to increased toxicity with irinotecan and sacituzumab-govitecan, but the impact on trastuzumab-deruxtecan and datopotamab-deruxtecan is less established.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Granada, Granada
- Hospital Universitario Clínico San Cecilio — Granada, Granada, Spain (Recruiting)
Study contacts
- Study coordinator: Isabel Blancas López-Barajas, MD, PhD
- Email: ensayosclinicosom.husc.sspa@juntadeandalucia.es
- Phone: +34 958 023265
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.