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

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