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

Overview

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

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 15, 2005

Interventions

  • Drug: tibolone
    • one tablet of 2.5 mg tibolone, per day, every day, for 14 ± 2 days (until the day before surgery).
  • Drug: placebo
    • Subjects were to take one tablet of tibolone-matched placebo, per day, every day, for 14 ± 2 days (until the day before surgery).

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary 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 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme Corp.
  • Provider of Information About this Clinical Study
    • Sponsor

Citations Reporting on Results

Kubista E, Planellas Gomez JV, Dowsett M, Foidart JM, Pohlodek K, Serreyn R, Nechushkin M, Manikhas AG, Semiglazov VF, Hageluken CC, Singer CF. Effect of tibolone on breast cancer cell proliferation in postmenopausal ER+ patients: results from STEM trial. Clin Cancer Res. 2007 Jul 15;13(14):4185-90.

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