This trial is active, not recruiting.

Condition breast cancer
Treatments side-effect questionnaires, research blood samples
Sponsor University of Chicago
Collaborator Translational Breast Cancer Research Consortium
Start date November 2009
End date May 2017
Trial size 240 participants
Trial identifier NCT00977119, 09-056-B, TBCRC 015


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Women with breast cancer receiving capecitabine as treatment for their breast cancer.
side-effect questionnaires
Paper or telephone questionnaire to report specific side-effects associated with their breast cancer treatment weekly
research blood samples
Blood samples for research on DNA before starting treatment and after 4 cycles of treatment

Primary Outcomes

Genetic variants of toxicity
time frame: 2 years

Secondary Outcomes

Time to toxicity based on genetics
time frame: 2 years
Multiple genetic variants as predictors
time frame: 2 years
Genome-wide association (potential)
time frame: 2 years
Correlative sample collection
time frame: 2 years

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Investigation of Genetic Determinants of Capecitabine Toxicity
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of Chicago.