A Study to Investigate the Effects of Tibolone (Livial®) on Breast Tissue in Postmenopausal Women With Breast Cancer (Study 32971)(P06469)

Study Overview
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Brief Summary
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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

Official Title
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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.

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: tibolone
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: healthy subjects
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Postmenopausal women of any age, requiring surgery for early invasive primary breast cancer, with estrogen receptor-positive tumor(s). Treated with tibolone | Drug: tibolone<br>* one tablet of 2.5 mg tibolone, per day, every day, for 14 ± 2 days (until the day before surgery).<br>* Other names: Livial®;|
| Placebo Comparator: Arm 2<br>Postmenopausal women of any age, requiring surgery for early invasive primary breast cancer, with estrogen receptor-positive tumor(s). Treated with placebo | Drug: placebo<br>* Subjects were to take one tablet of tibolone-matched placebo, per day, every day, for 14 ± 2 days (until the day before surgery).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apoptosis index; estrogen/progesterone/androgen receptors & isoforms; bcl-2, bax; pS2; SOX4; Apolipoprotein D; Angiogenesis parameters; estrogen levels, tibolone and tibolone metabolites. |  | Outcome parameters were measured during the trial as samples were received and at the end of the clinical phase. |