Status:
COMPLETED
Exemestane in Combination With Fulvestrant in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Collaborating Sponsors:
Pfizer
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00201864
Start Date
September 1 2005
End Date
February 1 2014
Last Update
July 26 2018
Active Locations (1)
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1
Ohio State University
Columbus, Ohio, United States, 43210