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.
- women with breast cancer in whom single agent capecitabine therapy is being considered
- aged 18 years and older
- 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
Last updated: 08/13/2012
NCT ID: NCT00977119