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

M.D. Anderson Cancer Center

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: Phlebotomy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00478686

2006-1003

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 102 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

102 participants in 3 patient groups

Severe Toxicity

Description:

Patients who experienced severe toxicity (at least one grade 4 side effect) with capecitabine chemotherapy

Treatment:

Procedure: Phlebotomy

Dose-Limiting Toxicity

Description:

Patients who experienced dose-limiting toxicity (at least one grade 3, or recurrent grade 2, side effect)with capecitabine chemotherapy

Treatment:

Procedure: Phlebotomy

Low/No Toxicity

Description:

Patients who have experienced low/no toxicity (none or only side effects at grade 1 \& 2) with capecitabine chemotherapy.

Treatment:

Procedure: Phlebotomy