Status:
COMPLETED
Fulvestrant (FASLODEX™) as a Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer
Lead Sponsor:
AstraZeneca
Conditions:
Breast Cancer
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate fulvestrant in the preliminary stage of breast cancer treatment and assess the relationship between dose, exposure, degree of reduction in tumor markers, and e...
Eligibility Criteria
Inclusion
- Postmenopausal women defined as women who have stopped having menstrual periods
- Written informed consent to participate in the trial
- Biopsy confirmation of invasive breast cancer
- Evidence of hormone sensitivity
- Willingness to undergo biopsies
Exclusion
- Any previous treatment for breast cancer
- Unwillingness to stop taking any drug known to affect sex hormonal status or a patient in which it would be inappropriate to stop.
- Any severe concurrent condition that would preclude surgery or that would jeopardize compliance with the study, e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus
- The presence of more than one primary tumor
- History of hypersensitivity to castor oil
- History of known bleeding disorders
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT00093002
Start Date
June 1 2004
End Date
July 1 2007
Last Update
June 12 2008
Active Locations (31)
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1
Research Site
Little Rock, Arkansas, United States
2
Research Site
Boston, Massachusetts, United States
3
Research Site
Winchester, Massachusetts, United States
4
Research Site
Albuquerque, New Mexico, United States