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

This study has been completed.
Sponsor:
Collaborator:
International Collaborative Cancer Group (ICCG)
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00038467
First received: May 31, 2002
Last updated: May 9, 2013
Last verified: May 2013
History of Changes

May 31, 2002
May 9, 2013
February 1998
June 2003   (final data collection date for primary outcome measure)
Disease Free Survival (DFS) [ Time Frame: June 2003, February 2006, December 2009, February 2013 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00038467 on ClinicalTrials.gov Archive Site
  • Overall survival (OS) [ Time Frame: June 2003, February 2006, December 2009, February 2013 ] [ Designated as safety issue: No ]
  • Incidence of second breast cancer (in contralateral breast) [ Time Frame: June 2003, February 2006, December 2009, February 2013 ] [ Designated as safety issue: No ]
  • Long term tolerability of the regimens [ Time Frame: February 2006 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Breast Neoplasms
  • 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.
  • Active Comparator: B
    Intervention: Drug: Tamoxifen
  • Experimental: A
    Intervention: Drug: Exemestane
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4738
March 2013
June 2003   (final data collection date for primary outcome measure)

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
Female
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   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
 
NCT00038467
96-OEXE-031, A5991012
Yes
Pfizer
Pfizer
International Collaborative Cancer Group (ICCG)
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

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