Regiospecific ortho-C-H Allylation of Benzoic Acids.
A Stefania Trita, Agostino Biafora, Martin Pichette Drapeau...
https://pubmed.ncbi.nlm.nih.gov/29411933Actively Recruiting
Age: 18Years +
All Genders
ID07582887
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
Led by Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental · Updated on 2026-05-13
70
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how genetic differences affect the way certain antibody-drug conjugates (ADCs) used in treating locally advanced or metastatic breast cancer are processed in the body. Specifically, they are focusing on the UGT1A1 gene, which influences how the active drug components are eliminated and how toxic side effects may develop. Variants in this gene can increase the risk of severe side effects such as neutropenia and diarrhea, especially with drugs like sacituzumab-govitecan, trastuzumab-deruxtecan, and datopotamab-deruxtecan. The study monitors patients receiving standard clinical doses of these three ADCs as part of their breast cancer treatment. Each drug is given according to routine clinical practice and product guidelines. The research evaluates the presence of UGT1A1 genetic variants and their association with the severity of drug-related toxicities over time. Participants will be followed for up to two years, during which researchers will track severe side effects related to the drugs. Genetic testing will be done at the start to identify UGT1A1 variants. The study aims to develop a predictive model linking these genetic markers to toxicity risk. Patients will receive their usual cancer care while contributing information through genetic analysis and monitoring of treatment outcomes.
CONDITIONS
Brief Title
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
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Patients diagnosed with breast cancer starting or undergoing treatment with sacituzumab govitecan, trastuzumab-deruxtecan, or datopotamab deruxtecan
- Signed informed consent provided for genetic study
You will not qualify if you...
- Patients not treated with the specified antibody-drug conjugates
- Refusal to provide informed consent for genetic analysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 2 years
Participants who undergo routine care with the specified antibody-drug conjugates are observed for toxicity and genetic factors.
Visits aligned with routine clinical treatment schedules
Trial Site Locations
Total: 1 location
1
Hospital Universitario Clínico San Cecilio
Granada, Granada, Spain, 18016
Actively Recruiting
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Research Team
I
Isabel Blancas López-Barajas, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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https://pubmed.ncbi.nlm.nih.gov/35324390Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer.
Aditya Bardia, Sara A Hurvitz, Sara M Tolaney...
https://pubmed.ncbi.nlm.nih.gov/33882206