Evaluating The Safety Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy In Postmenopausal Early Breast Cancer Patients

Back to Search
Print
Bookmark Trial

NCT01155063

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

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

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Early Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Postmenopausal females.

- Patients who have had surgical treatment for histological confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.

- Patients who are disease-free after 2 or 3 years of adjuvant tamoxifen treatment.

- Patients whose tumour was estrogen receptor positive (ER+).

- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

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


- Patients for whom Aromasin® treatment is contraindicated (see SPC).


- Presence of metastasis or a contra lateral tumour.


- Other adjuvant endocrine therapy.


- Another concomitant antineoplastic treatment.


- Participation in a clinical trial with an investigational drug during the 30 days
prior to enrolment in the study.

NEED INFO?

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

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

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.

Advanced Search

Based on your search, you may also be interested in

Early Breast CancerA Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04)
NCT02187744
  1. Fountain Valley, California
  2. Kingwood, Texas
  3. Shenandoah, Texas
  4. Shenandoah, Texas
  5. Lesnoy, Minsk Region
  6. Hradec Kralove,
  7. Kecskemet, Bacs-kiskun
  8. Budapest,
  9. Budapest,
  10. Budapest,
  11. Miskolc,
  12. Szolnok,
  13. Milano, MI
  14. Roma, RM
  15. Roma, RM
  16. Roma, RM
  17. Gdynia,
  18. Lodz,
  19. Olsztyn,
  20. Kuzmolovo, Leningrad Region
  21. Ufa, Republic Bashkortost
  22. Kislino Settlement, Ryshkovskiy Village Council
  23. Pyatigorsk, Stavropol Region
  24. Volzhskiy, Volgograd Region
  25. Irkutsk,
  26. Kursk,
  27. Moscow,
  28. Moscow,
  29. Nizhniy Novgorod,
  30. Nizhniy Novgorod,
  31. Omsk,
  32. Saint-Petersburg,
  33. Saint-Petersburg,
  34. Saint-Petersburg,
  35. Saint-Petersburg,
  36. Saint-Petersburg,
  37. Saint-Petersburg,
  38. Velikiy Novgorod,
  39. Belgrade,
  40. Bratislava,
  41. Bratislava,
  42. Kosice,
  43. Chernihiv,
  44. Dnipropetrovsk,
  45. Kharkiv,
  46. Kharkiv,
  47. Khmelnytskyi,
  48. Kryvyi Rih,
  49. Lviv,
  50. Odesa,
  51. Sumy,
  52. Vinnytsia,
Female
18 Years+
years
MULTIPLE SITES
Early Breast CancerEvaluating The Safety Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy In Postmenopausal Early Breast Cancer Patients
NCT01155063
Female
18 Years+
years
MULTIPLE SITES
Early Breast CancerTalazoparib For Neoadjuvant Treatment Of Germline Brca1/2 Mutation Patients With Early Triple-negative Breast Cancer
NCT03499353
  1. Laguna Hills, California
  2. Mobile, Alabama
  3. Gilbert, Arizona
  4. Gilbert, Arizona
  5. Fayetteville, Arkansas
  6. Rogers, Arkansas
  7. Camarillo, California
  8. Duarte, California
  9. Duarte, California
  10. Fountain Valley, California
  11. Fountain Valley, California
  12. Fountain Valley, California
  13. Glendale, California
  14. Long Beach, California
  15. Long Beach, California
  16. Orange, California
  17. Orange, California
  18. Oxnard, California
  19. Redlands, California
  20. Stanford, California
  21. Stanford, California
  22. Stanford, California
  23. Ventura, California
  24. West Covina, California
  25. Whittier, California
  26. Whittier, California
  27. Aurora, Colorado
  28. Boulder, Colorado
  29. Colorado Springs, Colorado
  30. Denver, Colorado
  31. Denver, Colorado
  32. Englewood, Colorado
  33. Lakewood, Colorado
  34. Littleton, Colorado
  35. Lone Tree, Colorado
  36. Longmont, Colorado
  37. Parker, Colorado
  38. Pueblo, Colorado
  39. Thornton, Colorado
  40. Aventura, Florida
  41. Fleming Island, Florida
  42. Jacksonville Beach, Florida
  43. Jacksonville, Florida
  44. Jacksonville, Florida
  45. Jacksonville, Florida
  46. Jacksonville, Florida
  47. Jacksonville, Florida
  48. Saint Augustine, Florida
  49. Atlanta, Georgia
  50. Atlanta, Georgia
  51. Atlanta, Georgia
  52. Atlanta, Georgia
  53. Atlanta, Georgia
  54. Atlanta, Georgia
  55. Atlanta, Georgia
  56. Newnan, Georgia
  57. Arlington Heights, Illinois
  58. Chicago, Illinois
  59. Chicago, Illinois
  60. Chicago, Illinois
  61. Chicago, Illinois
  62. Chicago, Illinois
  63. Niles, Illinois
  64. Baton Rouge, Louisiana
  65. Columbus, Mississippi
  66. Grenada, Mississippi
  67. Jackson, Mississippi
  68. Jackson, Mississippi
  69. New Albany, Mississippi
  70. Oxford, Mississippi
  71. Southaven, Mississippi
  72. Starkville, Mississippi
  73. Florham Park, New Jersey
  74. Phillipsburg, New Jersey
  75. Phillipsburg, New Jersey
  76. Toledo, Ohio
  77. Toledo, Ohio
  78. Portland, Oregon
  79. Portland, Oregon
  80. Portland, Oregon
  81. Tualatin, Oregon
  82. Allentown, Pennsylvania
  83. Allentown, Pennsylvania
  84. Bethlehem, Pennsylvania
  85. Bethlehem, Pennsylvania
  86. Coaldale, Pennsylvania
  87. Easton, Pennsylvania
  88. Easton, Pennsylvania
  89. Gettysburg, Pennsylvania
  90. Greensburg, Pennsylvania
  91. Monroeville, Pennsylvania
  92. Philadelphia, Pennsylvania
  93. Pittsburgh, Pennsylvania
  94. Pittsburgh, Pennsylvania
  95. Pittsburgh, Pennsylvania
  96. Pittsburgh, Pennsylvania
  97. Quakertown, Pennsylvania
  98. Stroudsburg, Pennsylvania
  99. Uniontown, Pennsylvania
  100. Washington, Pennsylvania
  101. Sioux Falls, South Dakota
  102. Bartlett, Tennessee
  103. Collierville, Tennessee
  104. Harrogate, Tennessee
  105. Jefferson City, Tennessee
  106. Knoxville, Tennessee
  107. Knoxville, Tennessee
  108. Memphis, Tennessee
  109. Morristown, Tennessee
  110. Newport, Tennessee
  111. Allen, Texas
  112. Arlington, Texas
  113. Arlington, Texas
  114. Austin, Texas
  115. Austin, Texas
  116. Austin, Texas
  117. Dallas, Texas
  118. Denton, Texas
  119. Houston, Texas
  120. Houston, Texas
  121. Houston, Texas
  122. Houston, Texas
  123. Irving, Texas
  124. Irving, Texas
  125. Irving, Texas
  126. McKinney, Texas
  127. New Braunfels, Texas
  128. Plano, Texas
  129. Round Rock, Texas
  130. San Antonio, Texas
  131. Chesapeake, Virginia
  132. Hampton, Virginia
  133. Newport News, Virginia
  134. Norfolk, Virginia
  135. Virginia Beach, Virginia
  136. Vancouver, Washington
  137. Vancouver, Washington
  138. Madison, Wisconsin
  139. Madison, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Evaluating The Safety Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy In Postmenopausal Early Breast Cancer Patients
Official Title A Non-Interventional Observational Study Evaluating The Effects Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy On Safety In Postmenopausal And Hormone Receptors Positive Early Breast Cancer Patients
Brief Summary Evaluating the safety, tolerability and efficacy of Aromasin® when used in routine clinical practice, evaluating adherence to prescribed Aromasin® treatment and to understand reasons for early discontinuation.
Detailed Description This study was terminated on 01-Aug-2011 due to very low potential to enroll planned number of patients or any sufficient number of patients for complete statistical analyses. This study is not being terminated because of safety or efficacy concerns.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy
Condition Early Breast Cancer
Intervention Other: Aromasin (exemestane)
Aromasin (exemestane), tablets 25 mg, once a day
Other Name: Aromasin, exemestane
Study Groups/Cohorts Main Group
Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy
Intervention: Other: Aromasin (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 Terminated
Actual Enrollment
 (submitted: August 17, 2012)		89
Original Estimated Enrollment
 (submitted: June 29, 2010)		600
Actual Study Completion Date September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Postmenopausal females.
  • Patients who have had surgical treatment for histological confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.
  • Patients who are disease-free after 2 or 3 years of adjuvant tamoxifen treatment.
  • Patients whose tumour was estrogen receptor positive (ER+).
  • Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

  • Patients for whom Aromasin® treatment is contraindicated (see SPC).
  • Presence of metastasis or a contra lateral tumour.
  • Other adjuvant endocrine therapy.
  • Another concomitant antineoplastic treatment.
  • Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.
Sex/Gender
Sexes Eligible for Study:Female
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01155063
Other Study ID Numbers A5991092
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2012