| Exclusion Criteria: | 1) Have received any prior to chemotherapy.
2) Had prior therapy with an ErbB1 and/or ErbB2 inhibitor.
3) Are receiving concurrent anti-cancer therapy (chemotherapy, immunotherapy, and biologic therapy) while taking study medication.
4) Have Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Women with ulcerative colitis are also excluded.
5) Have a concurrent disease or condition that would make the woman inappropriate for study participation, or any serious medical disorder that would interfere with the woman's safety.
6) Have an active or uncontrolled infection.
7) Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
8) Have active cardiac disease, defined as one or more of the following: history of uncontrolled of symptomatic angina, history of arrhythmias requiring medications, or clinically significant; myocardial infarction < 6 months from study entry; uncontrolled or symptomatic congestive heart failure; ejection fraction below the institutional normal limit; any other cardiac condition, which is in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
9) Are pregnant or breastfeeding.
10) Have received concurrent treatment with an investigational agent clinical trial.
11) Use of any prohibited medications concurrently with lapatinib therapy.
12) Have used investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication.
13) Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to any of the agents used in this study or their excipients.
14) Are receiving therapeutic anti-coagulation therapy (i.e. warfarin, heparin) |