Breast CancerNCT00418236
Effect of Bazedoxifene, Raloxifene, and Placebo on Breast Density
An observational study of Breast Cancer, run by Wyeth is now a wholly owned subsidiary of Pfizer at 37 sites in 14 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 63 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 400 participants
- Where
- 37 sitesin 14 countries
- Study dates
- Oct 2006to Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 63 years
- Women only
- No healthy volunteers
- Adult
- 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.
Trial locations and contacts
37 sites in 14 countries.
37 sites in 14 countries
United States10 sites
Study site
Billings, Montana, 59101
Study site
Bismarck, North Dakota, 58503
Study site
Bozeman, Montana, 59715
Study site
Brooklyn Center, Minnesota, 55430
Study site
Fargo, North Dakota, 58104
Study site
Jamestown, North Dakota, 58401
Study site
Meridian, Idaho, 83642
Study site
San Diego, California, 92108
Study site
Upland, California, 91786
Study site
Watertown, South Dakota, 57201
Canada4 sites
Study site
Québec, Quebec, G1V 3M7
Study site
Sherbrooke, Quebec, J1H 4J6
Study site
Vancouver, British Columbia, V5Z 2N6
Study site
Winnipeg, Manitoba, R3A 1M3
South Africa4 sites
Study site
Johannesburg, 2196
Study site
Parow, 7500
Study site
Pretoria
Study site
Somerset West, 7130
Brazil3 sites
Study site
Goiânia, 74175-080
Study site
Mato Grosso, 78008-400
Study site
Sorocaba, São Paulo, 18095-458
Romania3 sites
Study site
Bucharest, 70231
Study site
Cluj-Napoca, 3400
Study site
Iasi, Jud. Iasi, 6600
About this study
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
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.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2007 (estimated)
- Study startOct 2006
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of PfizerTrial Manager, Principal investigator, For Bulgaria, WVPIMED@wyeth.comTrial Manager, Principal investigator, For Croatia, WPBUMED@wyeth.comTrial Manager, Principal investigator, For Denmark, medinfonord@wyeth.comTrial Manager, Principal investigator, For Estonia, WVPMED@wyeth.comTrial Manager, Principal investigator, For Netherlands, trials-NL@wyeth.comTrial Manager, Principal investigator, For Poland, WPWZMED@wyeth.comTrial Manager, Principal investigator, For Romania, WVPIMED@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418236
- Sponsor's protocol ID
- 3068A1-400
- Status last verified
- Dec 2007
- First submitted
- 2 Jan 2007
- Last updated
- 19 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00418236
- Acronym / sponsor ID
- 3068A1-400
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Study completion
- Apr 2010 (actual)
- First posted
- 4 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 63 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Trial Manager principal investigator
For Bulgaria, WVPIMED@wyeth.com
Trial Manager principal investigator
For Croatia, WPBUMED@wyeth.com
37 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Wyeth is now a wholly owned subsidiary of Pfizer at 37 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Canada, South Africa, Brazil, Romania and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2010.