EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer

This study will provide pre-approval drug access to lapatinib, in combination with capecitabine, to patients whose breast cancer had progressed on other therapies

Inclusion criteria: * May have received prior lapatinib in another trial. Previous capecitabine (as previous agent or non-lapatinib containing regimen) is also permitted. * Prior treatment with hormonal therapy is allowed. * Must have advanced or metastatic breast cancer with progression (as assessed by modified RECIST) after prior therapy, which must include all of the following: prior treatment with an anthracycline, a taxane, and trastuzumab alone or in combination with other therapy. Trastuzumab must have been administered in the adjuvant, or locally advanced or metastatic setting. * Must have tumors that overexpress ErbB2 defined as +3 by IHC or FISH positive for ErbB2 gene amplification. The status of ErbB2 expression must be documented prior to study entry. * Must be \>/= 18 years of age * Life expectancy of \> 8 weeks * Must have recovered from side effects of previous treatment * Patients with CNS mets are eligible provided treatment with prohibited medications as listed in the protocol are not required * Cardiac ejection fraction must be within the institutional range of normal as measured by ECHO. MUGA scans are allowed if ECHOs cannot be performed * Able to swallow and retain oral medications * Must have adequate hematologic, hepatic and renal function Exclusion criteria: * Pregnant or lactating females * Malabsorption syndrome, disease significantly affecting GI function, or resection of the stomach or bowel, or ulcerative colitis * Concurrent disease or condition that would make the patient inappropriate for study participation * Unresolved or unstable toxicity from prior administration of another investigational drug and/or prior cancer treatment * Uncontrolled infection * Active cardiac disease defined as history of uncontrolled or symptomatic angina; history of arrhythmias requiring medication, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation; MI \< 6 months from study entry; uncontrolled or symptomatic CHF; ejection fraction below the institutional normal limit; any other cardiac condition that would make this protocol unreasonably hazardous for the patient * Receiving concurrent chemotherapy (other than capecitabine), radiation therapy, immunotherapy, biologic therapy or hormonal therapy for cancer. Concurrent therapy with bisphosphonates is allowed * History of allergic reaction attributed to compounds of similar composition to lapatinib or any excipients * History of allergic reactions attributed to compounds of similar chemical composition to capecitabine, fluorouracil or excipients * Known DPD deficiency