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.

Condition	Treatment or Intervention	Phase
Breast Cancer Metastases	Drug: Lapatinib	Phase II

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Criteria

Inclusion criteria:

• 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 intent surgery.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Documented amplification of ErbB2 by Fluorescense in situ hybridization (FISH)
• Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST)
• Adequate renal, hepatic and cardiac function

Exclusion criteria:

• 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 entry.
• 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.

Chile
      Santiago,  NA,  Chile; Recruiting
      Santiago,  NA,  Chile; Recruiting
      Santiago,  NA,  Chile; Not yet recruiting
China
      Hong Kong,  NA,  China; Recruiting
India
      New Delhi,  110085,  India; Recruiting
      Pune,  411001,  India; Recruiting
Malaysia
      Penang,  11200,  Malaysia; Recruiting
      Kota Bharu,  na,  Malaysia; Recruiting
Mexico
      Mexico, D.F.,  03100,  Mexico; Not yet recruiting
      Merida, Yucatan,  Mexico; Not yet recruiting
Pakistan
      Lahore,  na,  Pakistan; Not yet recruiting
Peru
      Lima,  NA,  Peru; Recruiting
      Lima,  NA,  Peru; Recruiting
Singapore
      Singapore,  169610,  Singapore; Recruiting
      Singapore,  258500,  Singapore; Recruiting
Taiwan, Province of China
      Taipei City,  150,  Taiwan, Province of China; Not yet recruiting
      Taipei,  na,  Taiwan, Province of China; Not yet recruiting

Study ID Numbers:  EGF20009
Record last reviewed:  October 2004
Record first received:  August 18, 2004
ClinicalTrials.gov Identifier:  NCT00089999
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10