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

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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