A Phase 3 interventional study of exemestane and tamoxifen in Breast Neoplasms, sponsored by Pfizer. Completed at 59 sites in France. Open to female participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2011-12-23.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
To compare recurrence free survival between two treatment groups (5 years with exemestane vs 2.5 to 3 years tamoxifen followed by 2 to 2.5 years of exemestane for a total duration of 5 years)
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. Link to TEAM Trial [971-ONC-0028-081/A5991026] Study Results: http://clinicaltrials.gov/ct2/show/results/NCT00036270?term=971-ONC-0028-081\&rank=1
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 9,779 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: exemestane
Drug: tamoxifen
On tablet of 25 mg per day during 5 years
Also known as: Aromasin
Two tablets of tamoxifen 10 mg per day during 2.5 to 3 years followed by one tablet of exemestane 25 mg per day during 2 to 2.5 years for a total duration of 5 years of treatment
Also known as: Kessar
To compare recurrence free survival between two treatment groups.
Time frame: 2.75 years and 5 years
The quality of life of patients treated with exemestane to that of patients treated with tamoxifen
Time frame: Every 3 months during first year then every 6 months for 4 years
Overall survival between the 2 treatment groups
Time frame: Every 3 months during first year then every 6 months for 4 years
Incidence of a second breast cancer (contralateral) between the 2 treatment groups
Time frame: Every 3 months during first year then every 6 months for 4 years
General tolerance in the short- and long-term between the 2 treatment groups
Time frame: Every 3 months during first year then every 6 months dor 4 years
This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
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