Investigation of Genetic Determinants of Capecitabine Toxicity

Study Overview
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Brief Summary
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The purpose of this study is to identify possible genetic polymorphisms that contribute to specific toxicities associated with capecitabine (hand-foot syndrome, diarrhea, and neutropenia). Additionally, this study will look at gene polymorphisms in patients experiencing the toxicities of interest, the frequency of polymorphisms and differences in drug metabolism.

Official Title
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Investigation of Genetic Determinants of Capecitabine Toxicity

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Side-effect questionnaires
* Other: research blood samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women with breast cancer in whom single agent capecitabine therapy is being considered aged 18 years and older Exclusion Criteria: patients who have previously received capecitabine are excluded patients cannot be receiving capecitabine in combination with another cancer chemotherapy; concurrent use of trastuzumab is not permitted; concurrent use of zoledronic acid is allowed serum albumin less than 3.0 g/dL within the last 30 days creatinine clearance (CrCL) or glomerular filtration rate (GFR) less than 60 mL/min [/body surface area (BSA)] (within the last 30 days) inability to understand and give informed consent to participate patients with a history of inflammatory bowel disease requiring therapy or patients with chronic diarrhea syndromes or paralytic ileus patients with prior or concurrent pelvic irradiation patients who use an ostomy for fecal excretion there is no limit on the number of prior chemotherapies; the decision to use capecitabine is determined solely by the treating physician

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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 |
| --- | --- |
| Capecitabine<br>Women with breast cancer receiving capecitabine as treatment for their breast cancer. | Other: Side-effect questionnaires<br>* Paper or telephone questionnaire to report specific side-effects associated with their breast cancer treatment weekly<br>Other: research blood samples<br>* Blood samples for research on DNA before starting treatment and after 4 cycles of treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic variants of toxicity |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to toxicity based on genetics |  | 2 years | 
| Multiple genetic variants as predictors |  | 2 years | 
| Genome-wide association (potential) |  | 2 years | 
| Correlative sample collection |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, capecitabine