Effect of Bazedoxifene, Raloxifene, and Placebo on Breast Density


Last updated date
Study Location
San Diego, California, 92108, United States


Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center


By email


[email protected]

Call Now

Eligibility Criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-63 years


Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center


[email protected]


Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Breast CancerNeoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer
  1. Washington, District of Columbia
  2. Baltimore, Maryland
18 Years+
Breast CancerNeoadjuvant Letrozole and Palbociclib in Patients With Stage II-IIIB Breast Cancer, HR+, HER2 -
  1. Badalona, Barcelona
  2. Madrid,
  3. Valencia,
  4. Oporto,
18 Years+
Breast CancerPALbociclib CoLlaborative Adjuvant Study
  1. Mobile, Alabama
  2. Mobile, Alabama
  3. Anchorage, Alaska
  4. Anchorage, Alaska
  5. Phoenix, Arizona
  6. Greenbrae, California
  7. Greenbrae, California
  8. La Jolla, California
  9. Los Angeles, California
  10. Oakland, California
  11. Palo Alto, California
  12. Roseville, California
  13. Sacramento, California
  14. San Diego, California
  15. San Diego, California
  16. San Diego, California
  17. San Francisco, California
  18. San Francisco, California
  19. San Leandro, California
  20. Santa Clara, California
  21. South San Francisco, California
  22. Stanford, California
  23. Vallejo, California
  24. Walnut Creek, California
  25. Denver, Colorado
  26. Hartford, Connecticut
  27. New Britain, Connecticut
  28. Newark, Delaware
  29. Washington, District of Columbia
  30. Washington, District of Columbia
  31. Clearwater, Florida
  32. Jacksonville, Florida
  33. Miami Beach, Florida
  34. Miami, Florida
  35. Orlando, Florida
  36. Atlanta, Georgia
  37. Chicago, Illinois
  38. Chicago, Illinois
  39. Chicago, Illinois
  40. Decatur, Illinois
  41. Harvey, Illinois
  42. Joliet, Illinois
  43. Park Ridge, Illinois
  44. Peoria, Illinois
  45. Rockford, Illinois
  46. Skokie, Illinois
  47. Skokie, Illinois
  48. Urbana, Illinois
  49. Indianapolis, Indiana
  50. Muncie, Indiana
  51. Ames, Iowa
  52. Ames, Iowa
  53. Cedar Rapids, Iowa
  54. Des Moines, Iowa
  55. Waterloo, Iowa
  56. Lexington, Kentucky
  57. Louisville, Kentucky
  58. New Orleans, Louisiana
  59. Bangor, Maine
  60. Scarborough, Maine
  61. Annapolis, Maryland
  62. Baltimore, Maryland
  63. Baltimore, Maryland
  64. Baltimore, Maryland
  65. Baltimore, Maryland
  66. Baltimore, Maryland
  67. Baltimore, Maryland
  68. Bethesda, Maryland
  69. Salisbury, Maryland
  70. Silver Spring, Maryland
  71. Boston, Massachusetts
  72. Boston, Massachusetts
  73. Boston, Massachusetts
  74. Boston, Massachusetts
  75. Lowell, Massachusetts
  76. Plymouth, Massachusetts
  77. Ann Arbor, Michigan
  78. Grand Rapids, Michigan
  79. Livonia, Michigan
  80. Duluth, Minnesota
  81. Rochester, Minnesota
  82. Rochester, Minnesota
  83. Saint Cloud, Minnesota
  84. Saint Louis Park, Minnesota
  85. Saint Louis Park, Minnesota
  86. Kansas City, Missouri
  87. Rolla, Missouri
  88. Saint Louis, Missouri
  89. Saint Louis, Missouri
  90. Saint Louis, Missouri
  91. Springfield, Missouri
  92. Omaha, Nebraska
  93. Concord, New Hampshire
  94. Hooksett, New Hampshire
  95. Lebanon, New Hampshire
  96. Lebanon, New Hampshire
  97. Englewood, New Jersey
  98. Hackensack, New Jersey
  99. Albuquerque, New Mexico
  100. Albuquerque, New Mexico
  101. Bronx, New York
  102. Buffalo, New York
  103. East Syracuse, New York
  104. Jamaica, New York
  105. New Hyde Park, New York
  106. New York, New York
  107. New York, New York
  108. New York, New York
  109. Oneonta, New York
  110. Syracuse, New York
  111. Charlotte, North Carolina
  112. Durham, North Carolina
  113. Greensboro, North Carolina
  114. Pinehurst, North Carolina
  115. Rapid City, North Dakota
  116. Cleveland, Ohio
  117. Cleveland, Ohio
  118. Columbus, Ohio
  119. Mayfield Heights, Ohio
  120. Lawton, Oklahoma
  121. Oklahoma City, Oklahoma
  122. Oklahoma City, Oklahoma
  123. Portland, Oregon
  124. Dunmore, Pennsylvania
  125. Hershey, Pennsylvania
  126. Lancaster, Pennsylvania
  127. Philadelphia, Pennsylvania
  128. Philadelphia, Pennsylvania
  129. Philadelphia, Pennsylvania
  130. Philadelphia, Pennsylvania
  131. Pittsburgh, Pennsylvania
  132. Pittsburgh, Pennsylvania
  133. Wyomissing, Pennsylvania
  134. York, Pennsylvania
  135. Providence, Rhode Island
  136. Providence, Rhode Island
  137. Columbia, South Carolina
  138. Aberdeen, South Dakota
  139. Rapid City, South Dakota
  140. Sioux Falls, South Dakota
  141. Nashville, Tennessee
  142. Nashville, Tennessee
  143. Houston, Texas
  144. Houston, Texas
  145. Houston, Texas
  146. Laredo, Texas
  147. Salt Lake City, Utah
  148. Fairfax, Virginia
  149. Richmond, Virginia
  150. Charleston, West Virginia
  151. Appleton, Wisconsin
  152. Green Bay, Wisconsin
  153. La Crosse, Wisconsin
  154. Madison, Wisconsin
  155. Milwaukee, Wisconsin
  156. Milwaukee, Wisconsin
  157. Racine, Wisconsin
  158. Waukesha, Wisconsin
  159. Waukesha, Wisconsin
18 Years+
Advanced Information
Descriptive Information
Brief Title Effect of Bazedoxifene, Raloxifene, and Placebo on Breast Density
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
Brief 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.

Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Breast Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
 (submitted: January 2, 2007)
Original Enrollment Same as current
Actual Study Completion Date April 2010
Primary Completion Date Not Provided
Eligibility 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.
Sexes Eligible for Study:Female
Ages 18 Years to 63 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Argentina,   Brazil,   Bulgaria,   Canada,   Chile,   Croatia,   Denmark,   Estonia,   Mexico,   Netherlands,   Poland,   Romania,   South Africa,   United States
Removed Location Countries  
Administrative Information
NCT Number NCT00418236
Other Study ID Numbers 3068A1-400
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Bulgaria, [email protected]
Principal Investigator:Trial ManagerFor Croatia, [email protected]
Principal Investigator:Trial ManagerFor Denmark, [email protected]
Principal Investigator:Trial ManagerFor Estonia, [email protected]
Principal Investigator:Trial ManagerFor Netherlands, [email protected]
Principal Investigator:Trial ManagerFor Poland, [email protected]
Principal Investigator:Trial ManagerFor Romania, [email protected]
Principal Investigator:Trial ManagerFor South Africa, [email protected]
Principal Investigator:Trial ManagerFor Canada, [email protected]
Principal Investigator:Trial ManagerFor Mexico, [email protected]
Principal Investigator:Trial ManagerFor Argentina, [email protected]
Principal Investigator:Trial ManagerFor Chile, [email protected]
Principal Investigator:Trial ManagerFor Brazil, [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007