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

Back to Search
Print
Bookmark Trial

NCT00038467

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35205, 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]m

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
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

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
pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
Learn more ›

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 NeoplasmsFirst-line Palbociclib and Endocrine Therapy for Patients With HR+/HER2- Advanced Breast Cancer in the Real-world Setting.
NCT04767594
  1. Heidelberg,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Breast NeoplasmsA Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC)
NCT02819882
  1. Manresa, Barcelona
  2. Terrassa, Barcelona
  3. San Sebastián, Donostia
  4. Las Palmas de Gran Canaria, Gran Canaria
  5. Alcorcón, Madrid
  6. Fuenlabrada, Madrid
  7. Leganés, Madrid
  8. San Sebastián de los Reyes, Madrid
  9. Palma de Mallorca, Mallorca
  10. Pamplona, Navarra
  11. Santa Cruz de Tenerife, Tenerife
  12. Bilbao, Vizcaya
  13. A Coruña,
  14. Albacete,
  15. Alicante,
  16. Barcelona,
  17. Barcelona,
  18. Barcelona,
  19. Barcelona,
  20. Barcelona,
  21. Barcelona,
  22. Cáceres,
  23. Córdoba,
  24. León,
  25. Lugo,
  26. Madrid,
  27. Madrid,
  28. Murcia,
  29. Málaga,
  30. Salamanca,
  31. Sevilla,
  32. Toledo,
  33. Valencia,
  34. Valencia,
  35. Valencia,
  36. Valencia,
  37. Zaragoza,
  38. Zaragoza,
  39. Elche, Alicante
  40. Sagunto, Valencia
  41. Ávila,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
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
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