A Study to Investigate the Effects of Tibolone (Livial®) on Breast Tissue in Postmenopausal Women With Breast Cancer (Study 32971)(P06469) (STEM)
|ClinicalTrials.gov Identifier: NCT00725374|
Recruitment Status : Completed
First Posted : July 30, 2008
Last Update Posted : May 31, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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 who need to undergo surgery for primary breast cancer
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: tibolone Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Exploratory, Double-blind, Randomized, Placebo-controlled Trial to Investigate the Tissue Specific Effects of 2.5 mg Tibolone on Breast Cancer in Postmenopausal Women, in Particular on Breast Tissue Proliferation.|
|Actual Study Start Date :||December 15, 2002|
|Primary Completion Date :||April 15, 2005|
|Study Completion Date :||April 15, 2005|
Active Comparator: Arm 1
Postmenopausal women of any age, requiring surgery for early invasive primary breast cancer, with estrogen receptor-positive tumor(s). Treated with tibolone
one tablet of 2.5 mg tibolone, per day, every day, for 14 ± 2 days (until the day before surgery).
Other Name: Livial®
Placebo Comparator: Arm 2
Postmenopausal women of any age, requiring surgery for early invasive primary breast cancer, with estrogen receptor-positive tumor(s). Treated with placebo
Subjects were to take one tablet of tibolone-matched placebo, per day, every day, for 14 ± 2 days (until the day before surgery).
Primary Outcome Measures :
- The primary objective of this trial was to compare changes in the expression of the proliferation marker Ki-67 in malignant breast tissue after treatment with tibolone or placebo. [ Time Frame: The primary outcome measure, the proliferation marker Ki-67, was measured at screening (from the screening biopsy) and about 14 days later (from the surgically removed breast tumour tissue) ]
Secondary Outcome Measures :
- Apoptosis index; estrogen/progesterone/androgen receptors & isoforms; bcl-2, bax; pS2; SOX4; Apolipoprotein D; Angiogenesis parameters; estrogen levels, tibolone and tibolone metabolites. [ Time Frame: Outcome parameters were measured during the trial as samples were received and at the end of the clinical phase. ]
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