Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer (IES)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- Disease Free Survival (DFS) [ Time Frame: June 2003, February 2006, December 2009, February 2013 ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||February 1998|
|Study Completion Date:||March 2013|
|Primary Completion Date:||June 2003 (Final data collection date for primary outcome measure)|
|Active Comparator: B||
Tamoxifen 20 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
Exemestane 25 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|