Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer

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NCT00038467

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35205, United States
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- postmenopausal women with histologically or cytologically confirmed primary breast adenocarcinoma, receiving tamoxifen and have been treated with tamoxifen continuously for between 2 and 3 years and one month, and still free of disease

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- unresectable breast cancer


- ER negative primary tumor

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Breast NeoplasmsStudy Of CP-751,871 In Combination With Exemestane In Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer NCT00372996
  1. La Jolla, California
  2. La Jolla, California
  3. San Diego, California
  4. Washington, District of Columbia
  5. Davie, Florida
  6. Plantation, Florida
  7. Lexington, Kentucky
  8. Lexington, Kentucky
  9. Lexington, Kentucky
  10. Boston, Massachusetts
  11. Boston, Massachusetts
  12. Boston, Massachusetts
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  14. Boston, Massachusetts
  15. Boston, Massachusetts
  16. Minneapolis, Minnesota
  17. Minneapolis, Minnesota
  18. Minneapolis, Minnesota
  19. Burlington, North Carolina
  20. Durham, North Carolina
  21. Durham, North Carolina
  22. Durham, North Carolina
  23. Durham, North Carolina
  24. Durham, North Carolina
  25. Dallas, Texas
  26. Houston, Texas
  27. Houston, Texas
  28. Burlington, Vermont
  29. Burlington, Vermont
  30. Burlington, Vermont
  31. Burlington, Vermont
  32. Burlington, Vermont
  33. Burlington, Vermont
  34. La Plata, Buenos Aires
  35. La Plata, Buenos Aires
  36. La Plata, Buenos Aires
  37. La Plata, Buenos Aires
  38. Rosario, Santa Fe
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  41. Rosario, Santa Fé
  42. Cordoba,
  43. Leuven,
  44. Leuven,
  45. Wilrijk,
  46. Montreal, QC
  47. Santo Cristo, Rio de Janeiro
  48. Porto Alegre, Rio Grande do Sul
  49. Rio de Janeiro, RJ
  50. Porto Alegre, RS
  51. Porto Alegre, RS
  52. Sao Paulo, SP
  53. Porto Alegre,
  54. Rio De Janeiro,
  55. Edmonton, Alberta
  56. Montreal, Quebec
  57. Milano,
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  59. Padova,
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Breast NeoplasmsA Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer NCT00373256
  1. Bessemer, Alabama
  2. Birmingham, Alabama
  3. Birmingham, Alabama
  4. Birmingham, Alabama
  5. Birmingham, Alabama
  6. Birmingham, Alabama
  7. Daphne, Alabama
  8. Mobile, Alabama
  9. Mobile, Alabama
  10. Flagstaff, Arizona
  11. Sedona, Arizona
  12. Hot Springs, Arkansas
  13. Anaheim, California
  14. Antioch, California
  15. Antioch, California
  16. Baldwin Park, California
  17. Bellflower, California
  18. Fontana, California
  19. Fountain Valley, California
  20. Gilroy, California
  21. Hawthorne, California
  22. Hayward, California
  23. Irvine, California
  24. La Jolla, California
  25. Long Beach, California
  26. Los Angeles, California
  27. Los Angeles, California
  28. Los Angeles, California
  29. Martinez, California
  30. Milpitas, California
  31. Modesto, California
  32. Mountain View, California
  33. Oakland, California
  34. Ontario, California
  35. Orange, California
  36. Oxnard, California
  37. Panorama City, California
  38. Pinole, California
  39. Riverside, California
  40. Sacramento, California
  41. San Diego, California
  42. San Diego, California
  43. San Francisco, California
  44. San Francisco, California
  45. San Francisco, California
  46. San Jose, California
  47. San Sacramento, California
  48. Santa Clara, California
  49. Santa Monica, California
  50. Union City, California
  51. Vallejo, California
  52. Walnut Creek, California
  53. Woodland Hills, California
  54. Aurora, Colorado
  55. Boulder, Colorado
  56. Colorado Springs, Colorado
  57. Colorado Springs, Colorado
  58. Denver, Colorado
  59. Denver, Colorado
  60. Lakewood, Colorado
  61. Littleton, Colorado
  62. Lone Tree, Colorado
  63. Longmont, Colorado
  64. Parker, Colorado
  65. Thornton, Colorado
  66. Norwalk, Connecticut
  67. Boca Raton, Florida
  68. Coral Springs, Florida
  69. Davie, Florida
  70. Hollywood, Florida
  71. Inverness, Florida
  72. Lakeland, Florida
  73. Melbourne, Florida
  74. Miami, Florida
  75. Miami, Florida
  76. Miami, Florida
  77. Orlando, Florida
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  79. Tampa, Florida
  80. Winter Park, Florida
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  83. Columbus, Georgia
  84. Columbus, Georgia
  85. Decatur, Georgia
  86. Macon, Georgia
  87. Marietta, Georgia
  88. Chicago, Illinois
  89. Harvey, Illinois
  90. Skokie, Illinois
  91. Tinley Park, Illinois
  92. Vernon Hills, Illinois
  93. Avon, Indiana
  94. Beech Grove, Indiana
  95. Carmel, Indiana
  96. Fishers, Indiana
  97. Greenfield, Indiana
  98. Indianapolis, Indiana
  99. Indianapolis, Indiana
  100. Indianapolis, Indiana
  101. Indianapolis, Indiana
  102. Indianapolis, Indiana
  103. Jeffersonville, Indiana
  104. Mooresville, Indiana
  105. Munster, Indiana
  106. New Albany, Indiana
  107. Kansas City, Kansas
  108. Overland Park, Kansas
  109. Louisville, Kentucky
  110. Louisville, Kentucky
  111. Louisville, Kentucky
  112. Louisville, Kentucky
  113. Louisville, Kentucky
  114. Annapolis, Maryland
  115. Baltimore, Maryland
  116. Baltimore, Maryland
  117. Baltimore, Maryland
  118. Baltimore, Maryland
  119. Columbia, Maryland
  120. Randallstown, Maryland
  121. Burlington, Massachusetts
  122. Peabody, Massachusetts
  123. Coon Rapids, Minnesota
  124. Robbinsdale, Minnesota
  125. Ocean Springs, Mississippi
  126. Pascagoula, Mississippi
  127. Columbia, Missouri
  128. Kansas City, Missouri
  129. Kansas City, Missouri
  130. Kansas City, Missouri
  131. Lee's Summit, Missouri
  132. Fremont, Nebraska
  133. Grand Island, Nebraska
  134. Lincoln, Nebraska
  135. Lincoln, Nebraska
  136. Lincoln, Nebraska
  137. Lincoln, Nebraska
  138. Henderson, Nevada
  139. Henderson, Nevada
  140. Las Vegas, Nevada
  141. Las Vegas, Nevada
  142. Las Vegas, Nevada
  143. Las Vegas, Nevada
  144. Las Vegas, Nevada
  145. Las Vegas, Nevada
  146. Albuquerque, New Mexico
  147. Albuquerque, New Mexico
  148. Buffalo, New York
  149. Corning, New York
  150. Jamaica, New York
  151. Mineola, New York
  152. Cary, North Carolina
  153. Clinton, North Carolina
  154. Durham, North Carolina
  155. Goldsboro, North Carolina
  156. Hickory, North Carolina
  157. Kenansville, North Carolina
  158. Kinston, North Carolina
  159. Lenoir, North Carolina
  160. Pollocksville, North Carolina
  161. Raleight, North Carolina
  162. Raliegh, North Carolina
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  188. Seneca, South Carolina
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  192. Amarillo, Texas
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  1. Downey, California
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  5. Boca Raton, Florida
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  13. Miami, Florida
  14. Pembroke Pines, Florida
  15. Duluth, Georgia
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  17. Snellville, Georgia
  18. Avon, Indiana
  19. Indianapolis, Indiana
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  21. Covington, Louisiana
  22. Gretna, Louisiana
  23. Marrero, Louisiana
  24. Metairie, Louisiana
  25. Metairie, Louisiana
  26. New Orleans, Louisiana
  27. Shreveport, Louisiana
  28. Kensington, Maryland
  29. Rockville, Maryland
  30. Corinth, Mississippi
  31. Columbia, Missouri
  32. Billings, Montana
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  34. Albuquerque, New Mexico
  35. Charlotte, North Carolina
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  39. Charlotte, North Carolina
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  44. Tulsa, Oklahoma
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  48. Pittsburgh, Pennsylvania
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  53. Hermitage, Tennessee
  54. Lebanon, Tennessee
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  57. Nashville, Tennessee
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  66. Beaumont, Texas
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  68. Corpus Christi, Texas
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  72. Murray, Utah
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  75. West Provo, Utah
  76. West Valley City, Utah
  77. Richmond, Virginia
  78. Richmond, Virginia
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  80. Linz,
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  84. Liege,
  85. Namur,
  86. Turnhout,
  87. Yvoir,
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  89. Calgary, Alberta
  90. Oshawa, Ontario
  91. Montreal, Quebec
  92. Montreal, Quebec
  93. Montreal, Quebec
  94. Montreal, Quebec
  95. Montreal, Quebec
  96. Praha 4,
  97. Praha 5,
  98. Praha 5,
  99. Aalborg,
  100. Koebenhavn OE,
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  105. CAEN Cedex 5,
  106. Lyon,
  107. Nancy,
  108. Paris,
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  110. Frankenthal,
  111. Frankfurt am Main,
  112. Fuerstenwalde,
  113. Goettingen,
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  116. Stendal,
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  120. Athens,
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  125. Dublin,
  126. Dublin,
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  130. Milano,
  131. Palermo,
  132. Parma,
  133. Roma,
  134. Roma,
  135. Saronno (VA),
  136. Torino,
  137. Amsterdam,
  138. Sittard-geleen,
  139. Zwolle,
  140. Levanger,
  141. Oslo,
  142. Lodz,
  143. Lublin,
  144. Warszawa,
  145. Warszawa,
  146. Cluj-Napoca, Cluj
  147. Bucuresti, Sector 2
  148. Kuzmolovo, Vsevolozhsk district, Leningrad region
  149. Moscow,
  150. St. Petersburg,
  151. St. Petersburg,
  152. Barcelona,
  153. Burgos,
  154. Cadiz,
  155. La Coruña,
  156. Madrid,
  157. Madrid,
  158. Sevilla,
  159. Truro, Cornwall
  160. Chelmsford, Essex
  161. Harlow, Essex
  162. Burton upon Trent, Staffordshire
  163. Worthing, West Sussex
  164. Birmingham,
  165. Essex,
  166. London,
  167. Swansea,
  168. Truro,
  169. Worthing,
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  1. Marseille, Be1 01971
  2. Compiegne, Be1 02256
  3. Rennes, Be1 03677
  4. Brest, Be1 04292
  5. Aix en Provence,
  6. Amiens,
  7. Annecy Cedex,
  8. Avignon Cedex 2,
  9. Bayonne,
  10. Blois,
  11. Bordeaux CEDEX,
  12. Bordeaux,
  13. Brest,
  14. Cagne sur Mer,
  15. Chalon sur Saone,
  16. Chaumont,
  17. Croix,
  18. Dijon,
  19. Douai,
  20. Draguignan,
  21. Dunkerque,
  22. Evreux,
  23. Hyres,
  24. L'Union,
  25. Le Havre,
  26. Lille,
  27. Lorient,
  28. Lyon,
  29. Mareuil les Meaux,
  30. Marseille,
  31. Marseille,
  32. Marseille,
  33. Metz,
  34. Montauban,
  35. Montbeliard,
  36. Montelimar,
  37. Montpellier,
  38. Mougins,
  39. Nancy,
  40. Nantes Cedex 2,
  41. Neuilly,
  42. NICE Cedex 1,
  43. Nimes,
  44. Paris,
  45. Pessac,
  46. Quincy sous Senart,
  47. Reims,
  48. Ris Orangis,
  49. Saint Brieuc,
  50. Saint Nazaire,
  51. St Cloud,
  52. St Herblain,
  53. Strasbourg,
  54. Toulon,
  55. Toulouse,
  56. Toulouse,
  57. Vandoeuvre les Nancy,
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  59. Vannes,
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50 Years+
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MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer
Official Title  ICMJE Randomized Double-Blind Trial In Postmenopausal Women With Primary Breast Cancer Who Have Received Adjuvant Tamoxifen For 2-3 Years, Comparing Subsequent Adjuvant Exemestane Treatment With Further Tamoxifen
Brief Summary To compare the sequential administration of exemestane with administration of further tamoxifen until 5 years in postmenopausal women with operable breast cancer who have already received 2-3 years of adjuvant tamoxifen, in terms of disease-free survival (DFS), overall survival (OS), incidence of contralateral breast cancer and long-term tolerability.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • Drug: Tamoxifen
    Tamoxifen 20 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
  • Drug: Exemestane
    Exemestane 25 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
Study Arms  ICMJE
  • Active Comparator: B
    Intervention: Drug: Tamoxifen
  • Experimental: A
    Intervention: Drug: Exemestane
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2014)		4740
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date June 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • postmenopausal women with histologically or cytologically confirmed primary breast adenocarcinoma, receiving tamoxifen and have been treated with tamoxifen continuously for between 2 and 3 years and one month, and still free of disease

Exclusion Criteria:

  • unresectable breast cancer
  • ER negative primary tumor
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Bosnia and Herzegovina,   Bulgaria,   Croatia,   Czech Republic,   Denmark,   Egypt,   Estonia,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Ireland,   Israel,   Italy,   Luxembourg,   Malta,   Netherlands,   New Zealand,   Norway,   Peru,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Slovakia,   Slovenia,   South Africa,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries Former Serbia and Montenegro,   Montenegro
 
Administrative Information
NCT Number  ICMJE NCT00038467
Other Study ID Numbers  ICMJE 96-OEXE-031
A5991012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE International Collaborative Cancer Group
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP