A Study to Investigate the Effects of Tibolone (Livial®) on Breast Tissue in Postmenopausal Women With Breast Cancer (Study 32971)(COMPLETED) (STEM)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00725374
First received: July 28, 2008
Last updated: October 2, 2009
Last verified: October 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: tibolone Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by Schering-Plough:
Primary Outcome Measures:
- 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. [ 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) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Apoptosis index; estrogen/progesterone/androgen receptors & isoforms; bcl-2, bax; pS2; SOX4; Apolipoprotein D; Angiogenesis parameters; estrogen levels, tibolone and tibolone metabolites. [ Time Frame: Outcome parameters were measured during the trial as samples were received and at the end of the clinical phase. ] [ Designated as safety issue: Yes ]
| Enrollment: | 102 |
| Study Start Date: | December 2002 |
| Study Completion Date: | September 2005 |
| Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm 1
Postmenopausal women of any age, requiring surgery for early invasive primary breast cancer, with estrogen receptor-positive tumor(s). Treated with tibolone
|
Drug: tibolone
one tablet of 2.5 mg tibolone, per day, every day, for 14 ± 2 days (until the day before surgery).
Other Name: Livial®
|
|
Placebo Comparator: Arm 2
Postmenopausal women of any age, requiring surgery for early invasive primary breast cancer, with estrogen receptor-positive tumor(s). Treated with placebo
|
Drug: placebo
Subjects were to take one tablet of tibolone-matched placebo, per day, every day, for 14 ± 2 days (until the day before surgery).
|
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00725374 History of Changes |
| Other Study ID Numbers: | 32971 |
| Study First Received: | July 28, 2008 |
| Last Updated: | October 2, 2009 |
| Health Authority: | Netherlands: Medicines Evaluation Board (MEB) |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Tibolone Androgen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Antineoplastic Agents, Hormonal Antineoplastic Agents Estrogen Receptor Modulators Anabolic Agents Hormones |
ClinicalTrials.gov processed this record on May 23, 2013