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

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ewa Mrozek; Ohio State University Comprehensive Cancer Center
• Collaborator: Pfizer
• Treatments: Estradiol; Exemestane; Fulvestrant; Hormones

Criteria

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