Status:

COMPLETED

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

Lead Sponsor:

Organon and Co

Conditions:

Breast Cancer

Eligibility:

FEMALE

Phase:

PHASE3

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 ...

Eligibility Criteria

Inclusion

  • 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

  • healthy subjects

Key Trial Info

Start Date :

December 15 2002

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 15 2005

Estimated Enrollment :

102 Patients enrolled

Trial Details

Trial ID

NCT00725374

Start Date

December 15 2002

End Date

April 15 2005

Last Update

August 15 2024

Active Locations (0)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 0 (0 locations)

No Results Found

We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.