- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00418236
Effect of Bazedoxifene, Raloxifene, and Placebo on Breast Density
Evaluation of Changes in Mammographic Breast Density Associated With Bazedoxifene, Raloxifene, and Placebo in Postmenopausal Women: An Ancillary Study of Protocol 3068A1-301-WW
It has been shown that women who have dense breasts have an increased risk of breast cancer compared with women whose breasts are less dense. However, while breast density may be a risk factor, the etiology of the relationship between breast cancer and breast density is not understood. Furthermore, it is well recognized that breast cancer can still develop in women whose breasts are not dense.
At menopause, the amount of breast glandular tissue and stroma naturally decreases due to a lack of hormonal stimulation. This is characterized as a decrease in the mammographic density. Although certain medications, including hormone therapy (HT) and dopamine antagonists can increase breast density, these effects are reversible upon discontinuation of the specific agent. Other medications such as the selective estrogen receptor modulators (SERM), raloxifene (RAL) and tamoxifen, have been shown to not affect breast density and allow the normal age-related changes to occur. The effects of bazedoxifene (BZA), a new SERM, on breast density are not known. The purpose of this study is to examine the effect of BZA on breast density changes over 24 months in postmenopausal women. The results may be useful for clinicians to understand the effect of BZA on breast density and its mammographic effects.
This is an observational, multicenter, double-blind, randomized, placebo- and active comparator-controlled study. It is also an ancillary that will use women who are already participants in a phase 3 trial for fracture reduction (protocol 3068A1-301-WW; primary study). In the primary study, subjects received BZA 20 mg, BZA 40 mg, RAL 60 mg, or placebo. This ancillary study will request a subset of participants to use their mammograms taken in this study. Their mammogram will be digitized by a central imaging center. A single radiologist will perform the quantifications of breast density from the digitized mammograms.
Study Overview
Status
Conditions
Study Type
Enrollment
Contacts and Locations
Study Locations
-
-
-
Buenos Aires, Argentina
-
-
-
-
-
Goiania, Brazil, 74175-080
-
Mato Grosso, Brazil, 78008-400
-
-
Sao Paulo
-
Sorocaba, Sao Paulo, Brazil, 18095-458
-
-
-
-
-
Sofia, Bulgaria, 1431
-
Sofia, Bulgaria, 1303
-
-
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 2N6
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3A 1M3
-
-
Quebec
-
Quebec City, Quebec, Canada, G1V 3M7
-
Sherbrooke, Quebec, Canada, J1H 4J6
-
-
-
-
-
Santiago, Chile
-
-
-
-
-
Zadar, Croatia, 23000
-
Zagreb, Croatia, 10000
-
-
-
-
-
Vejle, Denmark, DK-7100
-
-
-
-
-
Tallin, Estonia, 101 28
-
Tartu, Estonia, 50410
-
-
-
-
-
Agarismo, Mexico, 11800
-
-
-
-
-
Amsterdam, Netherlands, 1081 HV
-
-
-
-
-
Krakow, Poland, 30510
-
Warszawa, Poland, 02-341
-
-
-
-
-
Bucharest, Romania, 70231
-
Cluj-Napoca, Romania, 3400
-
Iasi, Jud. Iasi, Romania, 6600
-
-
-
-
-
Johannesburg, South Africa, 2196
-
Parow, South Africa, 7500
-
Pretoria, South Africa
-
Somerset West, South Africa, 7130
-
-
-
-
California
-
San Diego, California, United States, 92108
-
Upland, California, United States, 91786
-
-
Idaho
-
Meridian, Idaho, United States, 83642
-
-
Minnesota
-
Brooklyn Center, Minnesota, United States, 55430
-
-
Montana
-
Billings, Montana, United States, 59101
-
Bozeman, Montana, United States, 59715
-
-
North Dakota
-
Bismark, North Dakota, United States, 58503
-
Fargo, North Dakota, United States, 58104
-
Jamestown, North Dakota, United States, 58401
-
-
South Dakota
-
Watertown, South Dakota, United States, 57201
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- Each subject must have participated or is currently participating in study 3068A1 301, and must satisfy all of the following criteria
- Has completed 24 months of treatment.
- Had a mammogram at the baseline visit and at the month 24 visit, and both are original films that are technically acceptable for reading.
- Was less than or equal to 62 years of age at the time of study randomization in the primary study.
- Was at least 80% compliant with test article administration.
- Did not take any medications 6 months prior to screening in the primary study or during the first 24 months of the study that could cause a change in breast density.
- Was enrolled at a site that has at least 4 subjects meeting all of the above inclusion criteria.
- Was enrolled at a clinical site that is still participating in the primary study.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Investigators
- Principal Investigator: Trial Manager, For Poland, WPWZMED@wyeth.com
- Principal Investigator: Trial Manager, For Romania, WVPIMED@wyeth.com
- Principal Investigator: Trial Manager, For South Africa, ZAFinfo@wyeth.com
- Principal Investigator: Trial Manager, For Brazil, xavierl@wyeth.com
- Principal Investigator: Trial Manager, For Mexico, gomezzlj@wyeth.com
- Principal Investigator: Trial Manager, For Canada, clintrialparticipation@wyeth.com
- Principal Investigator: Trial Manager, For Croatia, WPBUMED@wyeth.com
- Principal Investigator: Trial Manager, For Argentina, Scheima@wyeth.com
- Principal Investigator: Trial Manager, For Chile, scheima@wyeth.com
- Principal Investigator: Trial Manager, For Denmark, medinfonord@wyeth.com
- Principal Investigator: Trial Manager, For Estonia, WVPMED@wyeth.com
- Principal Investigator: Trial Manager, For Bulgaria, WVPIMED@wyeth.com
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 3068A1-400
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
-
Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer