Study Evaluating SKI-606 (Bosutinib) In Subjects With Breast Cancer

Phase II Study Of SKI-606 In Subjects With Advanced Or Metastatic Breast Cancer

The purpose of this study is to determine if SKI-606 (Bosutinib) is effective in the treatment of advanced or metastatic breast cancer. Patients must have current Stage IIIB, IIIC or IV breast cancer and have progressed after 1 to 3 prior chemotherapy regimens.

Inclusion Criteria:

• Stage IIIB, IIIC or IV breast cancer not curable with available therapy.
• Patients must have progressed after 1 but not more than 3 prior chemotherapy regimens.
• Life expectancy of at least 16 weeks.
• Ability to swallow whole capsules.

Exclusion Criteria:

• Use of or requirement for bisphosphonates within 8 weeks prior to screening.
• Any other cancer within 5 years of screening, except for basal cell carcinoma or cervical carcinoma in situ
• Uncontrolled cardiac disease including congestive heart failure, angina, heart attack, etc.
• Recent or ongoing significant gastrointestinal disorder