Association of Dihydropyrimidine Dehydrogenase (DPYD) Variants With Toxicity Related to Capecitabine

Study Overview
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Brief Summary
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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.

Detailed Description
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If you agree to take part in this study, 1 blood sample (about 2 tablespoons) will be drawn for use in genetic research. If you are unable to provide a blood sample, researchers will collect leftover tissue samples from your previously collected tumor tissue (from the time of the breast cancer diagnosis). The tumor samples will be used for genetic research. After the blood draw or tissue collection, your participation in this study will be over. The blood samples for the genetic research will be stored at Myriad Laboratories. Before your blood and/or tissue is sent to Myriad Laboratories for banking, your name and any personal identifying information will be coded to protect your privacy. M. D. Anderson will not have oversight of any leftover tissue and/or blood that will be banked by Myriad Laboratories for additional research. This is an investigational study. Up to 210 patients will take part in this study. All will be enrolled at M. D. Anderson.

Official Title
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A Retrospective Analysis of the Association of Dihydropyrimidine Dehydrogenase (DPYD) Variants With Toxicity Related to Capecitabine

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Phlebotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be registered for protocol ID 01-580 and only patients who were randomized to receive capecitabine will be included in the study. Patients must sign an informed consent for this protocol. Exclusion Criteria: 1) There are no exclusion criteria.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Severe Toxicity<br>Patients who experienced severe toxicity (at least one grade 4 side effect) with capecitabine chemotherapy | Procedure: Phlebotomy<br>* 5 to 7.5 milliliter (mL) Blood Sample<br>|
| Dose-Limiting Toxicity<br>Patients who experienced dose-limiting toxicity (at least one grade 3, or recurrent grade 2, side effect)with capecitabine chemotherapy | Procedure: Phlebotomy<br>* 5 to 7.5 milliliter (mL) Blood Sample<br>|
| Low/No Toxicity<br>Patients who have experienced low/no toxicity (none or only side effects at grade 1 & 2) with capecitabine chemotherapy. | Procedure: Phlebotomy<br>* 5 to 7.5 milliliter (mL) Blood Sample<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of DPYD variants in patients |  | 2 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Dihydropyrimidine Dehydrogenase, DPYD, DPYD Variants, Toxicity, Capecitabine, Xeloda