Study on the Tolerability of Lapatinib and Trastuzumab in Adults Aged 60 or Older with HER2 Positive Advanced Breast Cancer

Inclusion Criteria

• Have HER2-positive breast cancer that is locally advanced or has spread to other parts of the body.
• Both measurable and non-measurable disease are allowed.
• Life expectancy of more than 12 weeks.
• Women of childbearing potential and sexually active men must use effective contraception during the study and for six months after.
• Be in relatively good health with an ECOG performance status of 0 to 2.
• Have adequate blood counts and organ function as determined by specific tests.
• Be able to swallow and retain oral medication.
• Previous treatment with lapatinib or trastuzumab is allowed, but not in combination.
• Any number of prior cancer treatments is allowed.
• Must understand and agree to sign a written informed consent.

Exclusion Criteria

• Currently receiving other investigational treatments, chemotherapy, or targeted therapy.
• Have unstable or symptomatic brain metastases.
• Have a history of severe allergic reactions to similar drugs, unless controlled with premedication.
• Taking certain medications that affect how the body processes drugs.
• Have ongoing infections or psychiatric conditions that would interfere with the study.
• Unable to take oral medication or have conditions affecting drug absorption.
• Have active liver or bile duct disease, except for certain stable conditions.
• Have active heart disease or poorly controlled high blood pressure.
• Unable to comply with study monitoring requirements.