Effect of Bazedoxifene, Raloxifene, and Placebo on Breast Density
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Phase: Phase 4
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Trial Manager, Principal Investigator, Affiliation: For Bulgaria, WVPIMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Croatia, WPBUMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Denmark, medinfonord@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Estonia, WVPMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Netherlands, trials-NL@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Poland, WPWZMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Romania, WVPIMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For South Africa, ZAFinfo@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Canada, clintrialparticipation@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Mexico, gomezzlj@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Argentina, Scheima@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Chile, scheima@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Brazil, xavierl@wyeth.com
Summary
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.
Clinical Details
Official title: Evaluation of Changes in Mammographic Breast Density Associated With Bazedoxifene, Raloxifene, and Placebo in Postmenopausal Women: An Ancillary Study of Protocol 3068A1-301-WW
Study design: Retrospective
Eligibility
Minimum age: 18 Years.
Maximum age: 63 Years.
Gender(s): Female.
Criteria:
1. Each subject must have participated or is currently participating in study 3068A1 301,
and must satisfy all of the following criteria
2. Has completed 24 months of treatment.
3. Had a mammogram at the baseline visit and at the month 24 visit, and both are original
films that are technically acceptable for reading.
4. Was less than or equal to 62 years of age at the time of study randomization in the
primary study.
5. Was at least 80% compliant with test article administration.
6. 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.
7. Was enrolled at a site that has at least 4 subjects meeting all of the above inclusion
criteria.
8. Was enrolled at a clinical site that is still participating in the primary study.
Locations and Contacts
Buenos Aires, Argentina
Mato Grosso 78008-400, Brazil
Goiania 74175-080, Brazil
Sofia 1431, Bulgaria
Sofia 1303, Bulgaria
Santiago, Chile
Zagreb 10000, Croatia
Zadar 23000, Croatia
Vejle DK-7100, Denmark
Tallin 101 28, Estonia
Tartu 50410, Estonia
Agarismo 11800, Mexico
Amsterdam 1081 HV, Netherlands
Warszawa 02-341, Poland
Krakow 30510, Poland
Bucharest 70231, Romania
Iasi, Jud. Iasi 6600, Romania
Cluj-Napoca 3400, Romania
Somerset West 7130, South Africa
Parow 7500, South Africa
Johannesburg 2196, South Africa
Pretoria, South Africa
Vancouver, British Columbia V5Z 2N6, Canada
Upland, California 91786, United States
San Diego, California 92108, United States
Meridian, Idaho 83642, United States
Winnipeg, Manitoba R3A 1M3, Canada
Brooklyn Center, Minnesota 55430, United States
Billings, Montana 59101, United States
Bozeman, Montana 59715, United States
Jamestown, North Dakota 58401, United States
Bismark, North Dakota 58503, United States
Fargo, North Dakota 58104, United States
Quebec City, Quebec G1V 3M7, Canada
Sherbrooke, Quebec J1H 4J6, Canada
Sorocaba, Sao Paulo 18095-458, Brazil
Watertown, South Dakota 57201, United States
Additional Information
Starting date: October 2006
Ending date: September 2007
Last updated: December 3, 2007
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