Status:
COMPLETED
A Study to Investigate the Effects of Tibolone (Livial®) on Breast Tissue in Postmenopausal Women With Breast Cancer (Study 32971)(P06469)
Lead Sponsor:
Organon and Co
Conditions:
Breast Cancer
Eligibility:
FEMALE
Phase:
PHASE3
Brief Summary
The primary purpose of this study is to compare changes in the expression of the proliferation marker Ki-67 in malignant breast tissue after treatment with tibolone or placebo in postmenopausal women ...
Eligibility Criteria
Inclusion
- postmenopausal women of any age
- requiring surgery for early invasive primary breast cancer (clinically stage I or II; T1-T3; N0-1; M0), with estrogen receptor-positive tumor(s)
- body mass index between 18 and 2 kg/m2, inclusive
- must be willing to give voluntary written informed consent.
Exclusion
- healthy subjects
Key Trial Info
Start Date :
December 15 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2005
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00725374
Start Date
December 15 2002
End Date
April 15 2005
Last Update
August 15 2024
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