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

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: placebo; Drug: tibolone

• Registration Number: NCT00725374
• Lead Sponsor: Organon and Co

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 who need to undergo surgery for primary breast cancer

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12-15
• Primary Completion: 2005-04-15
• Study Completion: 2005-04-15
• Study First Submitted: 2008-07-28
• Study First Submitted QC: 2008-07-29
• Study First Posted: 2008-07-30
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	placebo	Postmenopausal women of any age, requiring surgery for early invasive primary breast cancer, with estrogen receptor-positive tumor(s). Treated with placebo
Arm 1	tibolone	Postmenopausal women of any age, requiring surgery for early invasive primary breast cancer, with estrogen receptor-positive tumor(s). Treated with tibolone

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.