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

Phase II Trial of Exemestane (Aromasin) in Combination With Fulvestrant (Faslodex) in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer

The purpose of this trial is to evaluate time to progression in women with hormone responsive advanced breast cancer treated with a combination of exemestane and fulvestrant.

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