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

• Status: Completed
• Trial end date: 2005-04-15
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Tibolone

Criteria

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