GW572016 In Patients With Advanced Or Metastatic Breast Cancer

Phase II Clinical Study of GW572016 in Patients With Advanced or Metastatic Breast Cancer

This study is designed to evaluate the efficacy and safety of GW572016 in patients with refractory breast cancer and consists of two cohorts of patients. Patients in Cohort A must have ErbB2 overexpressing tumors while patients in Cohort B must have non-ErbB2 overexpressing tumors. Patients eligible for this study must have advanced metastatic breast cancer who have previously received treatment with anthracycline and taxane.

Inclusion Criteria:

• Confirmed advanced (IIIb or Stage IV) breast cancer who have progressed on prior anthracycline and taxanes containing regimens + trastuzumab for cohort A patients.
• Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in performing strenuous activity.
• Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.

Exclusion Criteria:

• Patients with certain heart problems.