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

Organon and Co102 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

102

Conditions

Breast Cancer

Interventions

tiboloneDRUG

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

placeboDRUG

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

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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