Clinical trial · Observational
Association of Dihydropyrimidine Dehydrogenase (DPYD) Variants With Toxicity Related to Capecitabine
A Retrospective Analysis of the Association of Dihydropyrimidine Dehydrogenase (DPYD) Variants With Toxicity Related to Capecitabine
NCT00478686CI-TRIAL-00027415completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this laboratory research study is to identify possible differences in a gene among patients with breast cancer that cannot be treated by surgery. Researchers want to find out if differences in this gene may increase the risk of side effects from capecitabine.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Phlebotomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Severe Toxicity
- description
- Patients who experienced severe toxicity (at least one grade 4 side effect) with capecitabine chemotherapy
- interventionNames
- Procedure: Phlebotomy
- label
- Dose-Limiting Toxicity
- description
- Patients who experienced dose-limiting toxicity (at least one grade 3, or recurrent grade 2, side effect)with capecitabine chemotherapy
- interventionNames
- Procedure: Phlebotomy
- label
- Low/No Toxicity
- description
- Patients who have experienced low/no toxicity (none or only side effects at grade 1 \& 2) with capecitabine chemotherapy.
- interventionNames
- Procedure: Phlebotomy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Patients must be registered for protocol ID 01-580 and only patients who were randomized to receive capecitabine will be included in the study. 2. Patients must sign an informed consent for this protocol. Exclusion Criteria: 1\) There are no exclusion criteria.
References
Publications (0)
Data not yet available
No reference posted for this study.