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Effect of Bazedoxifene, Raloxifene, and Placebo on Breast Density

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00418236
First received: January 2, 2007
Last updated: August 17, 2010
Last verified: December 2007
  Purpose

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.


Condition Phase
Breast Cancer
Phase 4

Study Type: Observational
Study Design: Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Estimated Enrollment: 400
Study Start Date: October 2006
Study Completion Date: April 2010
  Eligibility

Ages Eligible for Study:   18 Years to 63 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418236

  Show 37 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Bulgaria, WVPIMED@wyeth.com
Principal Investigator: Trial Manager For Croatia, WPBUMED@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 Netherlands, trials-NL@wyeth.com
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 Canada, clintrialparticipation@wyeth.com
Principal Investigator: Trial Manager For Mexico, gomezzlj@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 Brazil, xavierl@wyeth.com
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00418236     History of Changes
Other Study ID Numbers: 3068A1-400
Study First Received: January 2, 2007
Last Updated: August 17, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Bazedoxifene
Bone Density Conservation Agents
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on November 25, 2014