This phase II study will evaluate and compare the efficacy and tolerability of two dose
schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with
advanced or metastatic breast cancer.
- Histologically confirmed invasive breast cancer with incurable stage IIIB, IIIC with
T4 lesion or stage IV disease at primary diagnosis or at relapse after curative
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Documented amplification of ErbB2 by Fluorescence in situ hybridization (FISH)
- Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST)
- Adequate renal, hepatic and cardiac function
- Prior chemotherapy, immunotherapy, biologic therapy or anti-ErbB1/ErbB2 therapy other
than adjuvant therapy. [Prior neo-adjuvant or adjuvant therapy (including
trastuzumab) will be allowed provided it was stopped at least 12 months before study
- Patients with active brain metastases
- Patients with bilateral breast cancer, bone metastases as the only disease site or
metastases to more than 30% of the hepatic parenchyma.