Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane

Back to Search
Print
Bookmark Trial

NCT00036270

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bessemer, Alabama, 35022, United States
See other locations
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.
Breast Neoplasms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically/cytologically confirmed adenocarcinoma of the breast, followed by adequate surgical resection and/or radiotherapy, and/or adjuvant chemotherapy, if indicated.

- Stage T1-3 N0-2 Mo, Any TNM stage BC for whom adjuvant hormonal therapy is being considered.

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


- Those patients not deemed to have had potentially curative primary surgical treatment
or one of the following criteria:


- Inflammatory breast cancer


- Histologically positive supraclavicular nodes


- Ulceration/infiltration of local skin metastasis


- Neoadjuvant chemotherapy


- Ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) without invasion


- ER and PR negative primary tumor or ER/PR unknown status.

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

Breast NeoplasmsEvaluation of Chemotherapy Prior to Surgery With or Without Zometa for Women With Locally Advanced Breast Cancer
NCT00242203
  1. St. Louis, Missouri
Female
18 Years+
years
MULTIPLE SITES
Breast NeoplasmsPAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY
NCT03423199
  1. Nagoya, Aichi
  2. Kashiwa, Chiba
  3. Matsuyama, Ehime
  4. Sapporo, Hokkaido
  5. Akashi, Hyogo
  6. Yokohama, Kanagawa
  7. Ōsaka-sayama, Osaka
  8. Minato-Ku, Tokyo
  9. Chiba,
  10. Fukuoka,
  11. Osaka,
  12. Seoul,
  13. Seoul,
  14. Singapore,
  15. Taipei,
  16. Taipei,
  17. Singapore,
  18. Gyeonggi-do,
  19. Soeul,
  20. Tokyo,
  21. Gyeonggi-do,
  22. Taipei,
  23. Gyeonggi-do,
Female
18 Years+
years
MULTIPLE SITES
Breast NeoplasmsPD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer
NCT01723774
  1. Birmingham, Alabama
  2. Scottsdale, Arizona
  3. Rochester, Minnesota
  4. Saint Louis, Missouri
Female
18 Years+
years
MULTIPLE SITES
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
  13. Boston, Massachusetts
  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
  39. Rosario, Santa Fe
  40. Rosario, Santa Fe
  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,
  58. Napoli,
  59. Padova,
  60. Amsterdam,
  61. Malmo,
  62. London,
  63. London,
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane
Official Title  ICMJE Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen For 2.5- 3 Years Followed By Exemestane (Aromasin) For A Total Of 5 Years As Adjuvant Therapy For Postmenopausal, Receptor Positive, Node Negative or Node Positive Breast Cancer Patients
Brief Summary

To compare the effects of exemestane for 5 years versus tamoxifen and exemestane given sequentially over 5 years in the adjuvant treatment of postmenopausal women with early breast cancer.

This Pfizer sponsored trial is part of an international collaboration of investigators conducting 7 similar yet independent studies in 9 countries. This study is designed to be part of the larger TEAM trial where the data from these 7 studies will be combined. A pre-specified analysis of the pooled data will be conducted.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • Drug: exemestane (Aromasin)
    exemestane, orally, 25 mg, for 5 years
    Other Name: aromasin
  • Drug: tamoxifen + exemestane
    tamoxifen, 20 mg, orally, daily, 2-3 years; followed by exemestane, orally, 25 mg, for a total of 5 years of therapy
Study Arms  ICMJE
  • Experimental: exemestane
    Intervention: Drug: exemestane (Aromasin)
  • Experimental: tamoxifen + exemestane
    Intervention: Drug: tamoxifen + exemestane
Publications *

*   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: June 29, 2011)		9779
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically/cytologically confirmed adenocarcinoma of the breast, followed by adequate surgical resection and/or radiotherapy, and/or adjuvant chemotherapy, if indicated.
  • Stage T1-3 N0-2 Mo, Any TNM stage BC for whom adjuvant hormonal therapy is being considered.

Exclusion Criteria:

  • Those patients not deemed to have had potentially curative primary surgical treatment or one of the following criteria:
  • Inflammatory breast cancer
  • Histologically positive supraclavicular nodes
  • Ulceration/infiltration of local skin metastasis
  • Neoadjuvant chemotherapy
  • Ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) without invasion
  • ER and PR negative primary tumor or ER/PR unknown status.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 50 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00036270
Other Study ID Numbers  ICMJE 971-ONC-0028-081
A5991026
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 Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2015

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