- Women aged greater than 18 years.
- Postmenopausal subjects
- Confirmed diagnosis of locally advanced (not amenable to curative surgery and/or
radiation) or metastatic breast cancer (Stage 3B or 4 respectively, by American Joint
Committee on Cancer Criteria)
- Extensive visceral disease
- Subjects with bone as the only site of disease
- Prior radiation therapy to the site of measurable disease for subjects with a solitary