A Exploratory, Double-blind, Randomized, Placebo-controlled Trial to Investigate the Tissue Specific Effects of 2.5 mg Tibolone on Breast Cancer in Postmenopausal Women, in Particular on Breast Tissue Proliferation.
N/A
N/A
Female
Breast Cancer
Trial Information
A Exploratory, Double-blind, Randomized, Placebo-controlled Trial to Investigate the Tissue Specific Effects of 2.5 mg Tibolone on Breast Cancer in Postmenopausal Women, in Particular on Breast Tissue Proliferation.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
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.
Outcome 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)
Safety Issue:
Yes
Authority:
Netherlands: Medicines Evaluation Board (MEB)
Study ID:
32971
NCT ID:
NCT00725374
Start Date:
December 2002
Completion Date:
September 2005
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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