Expanded Access Program for Lapatinib and Capecitabine in Metastatic Breast Cancer

Inclusion Criteria

• May have previously taken lapatinib in another study. Previous use of capecitabine is also allowed.
• Prior hormonal therapy is permitted.
• Must have advanced or metastatic breast cancer that has worsened after previous treatments, including anthracycline, taxane, and trastuzumab (alone or with other therapies). Trastuzumab must have been used in early, locally advanced, or metastatic stages.
• Tumors must show high levels of ErbB2, confirmed by specific tests before joining the study.
• Must be 18 years or older.
• Expected to live more than 8 weeks.
• Must have recovered from side effects of past treatments.
• Patients with brain metastases can join if they don't need certain restricted medications.
• Heart function must be normal, as shown by specific heart tests.
• Must be able to swallow and keep down oral medications.
• Must have adequate blood, liver, and kidney function.

Exclusion Criteria

• Pregnant or breastfeeding women.
• Conditions affecting digestion or absorption, such as certain stomach or bowel diseases or surgeries.
• Any other illness or condition that makes participation inappropriate.
• Unresolved side effects from previous experimental drugs or cancer treatments.
• Uncontrolled infections.
• Active heart disease, such as uncontrolled angina, certain arrhythmias, recent heart attack, or heart failure.
• Receiving other cancer treatments, except for bisphosphonates.
• Allergic reactions to drugs similar to lapatinib or its ingredients.
• Allergic reactions to drugs similar to capecitabine or its ingredients.
• Known deficiency in DPD enzyme.