This trial is active, not recruiting.

Condition breast cancer
Treatment phlebotomy
Sponsor M.D. Anderson Cancer Center
Collaborator Myrexis Inc.
Start date May 2007
End date May 2017
Trial size 210 participants
Trial identifier NCT00478686, 2006-1003


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective retrospective
Patients who experienced severe toxicity (at least one grade 4 side effect) with capecitabine chemotherapy
5 to 7.5 milliliter (mL) Blood Sample
Patients who experienced dose-limiting toxicity (at least one grade 3, or recurrent grade 2, side effect)with capecitabine chemotherapy
5 to 7.5 milliliter (mL) Blood Sample
Patients who have experienced low/no toxicity (none or only side effects at grade 1 & 2) with capecitabine chemotherapy.
5 to 7.5 milliliter (mL) Blood Sample

Primary Outcomes

Incidence of DPYD variants in patients
time frame: 2 Years

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title A Retrospective Analysis of the Association of Dihydropyrimidine Dehydrogenase (DPYD) Variants With Toxicity Related to Capecitabine
Principal investigator Vicente Valero, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.