Locally Advanced Breast Cancer: Individualized Treatment Based On Tumor Molecular Characteristics

Exclusion Criteria

• •Stage 0, Stage I, Stage IIA.
• •Previous XRT(Radiation therapy) or chemotherapy.
• •Presence of distant metastases documented clinically or radiographically with the exception of ipsilateral supraclavicular nodes.
• •Inflammatory breast cancer.
• •Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil.
• •Exclude pregnant or lactating woman.
• •Woman of childbearing potential with either a positive or no pregnancy test at baseline.
• •Woman of childbearing potential not using a reliable and appropriate contraceptive method.
• •(Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
• •Patient will agree to continue contraception for 30 days from the date of the last study drug administration.
• •Serious concurrent infections.
• •Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias ) or myocardial infarction within the last 12 months.
• •Patients who have had an organ allograft.
• •Patients with severe renal impairment (creatinine clearance below 30 mL/min \[Cockcroft and Gault43\]). In patients with moderate renal impairment (creatinine clearance 30-50 mL/min \[Cockcroft and Gault43\]) at baseline, a dose reduction to 75% of the XELODA starting dose is recommended. In patients with mild renal impairment (creatinine clearance 51-80 mL/min) no adjustment in starting dose is recommended.
• •In phase I studies, those with any abnormal renal function, since toxicity will likely be affected by the presence of any significant renal dysfunction.
• •Cockcroft and Gault Equation:
• •(140 - age \[yrs\]) (body wt \[kg\])
• •Creatinine clearance for males = --------------
• •(72) (serum creatinine \[mg/dL\])
• •Creatinine clearance for females = 0.85 x male value