Exemestane in Combination With Fulvestrant in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer

Inclusion Criteria:

- Proven breast cancer

- Metastatic or locally advanced breast cancer

- Hormonally responsive disease defined as estrogen (ER) and/ or progesterone receptor
(PR) positive (>10% staining by immunohistochemistry)

- Postmenopausal status

- No more than 1 prior chemotherapy for stage IV metastatic breast cancer allowed

- ECOG (Eastern Cooperative Oncology Group) performance status 0-2

- Adequate organ function

- Exclusion Criteria:

- No prior Exemestane or Fulvestrant

- Uncontrolled intercurrent illness including but not limited to:

- ongoing or active infection

- symptomatic congestive heart failure

- unstable angina pectoris

- cardiac arrhythmia

- myocardial infarction within the last 3 months

- psychiatric illness/social situations that would limit compliance with study

- Lymphangitic pulmonary disease; carcinomatous meningitis, bone marrow only metastases;
and a rising tumor marker without any other site of metastatic disease.

- Presence of bleeding diathesis or coagulopathy, patients requiring coumadin