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

NCT00725374 | Completed Phase 3

• 2 other identifiers: P0646932971
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Postmenopausal women of any age, requiring surgery for early invasive primary breast cancer, with estrogen receptor-positive tumor(s). Treated with tibolone

Drug: tibolone

Arm 2

PLACEBO COMPARATOR

Postmenopausal women of any age, requiring surgery for early invasive primary breast cancer, with estrogen receptor-positive tumor(s). Treated with placebo

Drug: placebo

Interventions

tibolone DRUG

one tablet of 2.5 mg tibolone, per day, every day, for 14 ± 2 days (until the day before surgery).

Also known as: Livial®

Arm 1

placebo DRUG

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

Arm 2

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• healthy subjects

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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. doi: 10.1158/1078-0432.CCR-06-2700.

  PMID: 17634547 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

tibolone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 30, 2008
• Study Start: December 15, 2002
• Primary Completion: April 15, 2005
• Study Completion: April 15, 2005
• Last Updated: August 15, 2024

Record last verified: 2022-02