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

Organon

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: tibolone; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00725374

P06469

32971

Details and patient eligibility

About

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

Enrollment: 102 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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102 participants in 2 patient groups, including a placebo group

Arm 1

Active Comparator group

Description:

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

Treatment:

Drug: tibolone

Arm 2

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo