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

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00201864

Run by

Ohio State University Comprehensive Cancer Center

People needed

40

Starts

2005-09-01

Expected to finish

2014-02-01

Last updated by the study team

2018-07-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.