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

Breast Cancer Clinical Trial

— STEM  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725374
• Other study ID #: P06469
• Secondary ID: 32971
• Status: Completed
• Phase: Phase 3
• Start date: December 15, 2002
• Est. completion date: April 15, 2005

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: April 15, 2005
• Est. primary completion date: April 15, 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.