Official Title: “Multicenter, Randomized, Open-Label Study To Compare The Efficacy, Tolerance And Quality Of Life Of 5 Years Of Adjuvant Exemestane (Aromasin) Therapy With 2.5 To 3 Years Of Adjuvant Tamoxifen Therapy, Followed By 2 To 2.5 Years Of Exemestane For A Total Duration Of 5 Years To Treat HR+ Post-Menopausal Patients With Non-Metastatic Breast Cancer”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2008

Intervention(s) in this Clinical Trial

• Drug: tamoxifen
  • 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
• Drug: exemestane
  • On tablet of 25 mg per day during 5 years

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Active Comparator: B

Primary Measures

• To compare recurrence free survival between two treatment groups.
  • Time Frame: 2.75 years and 5 years
    Safety Issue?: Yes

Secondary Measures

• Overall survival between the 2 treatment groups
  • Time Frame: Every 3 months during first year then every 6 months for 4 years
    Safety Issue?: Yes
• 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
    Safety Issue?: Yes
• 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
    Safety Issue?: Yes
• 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
    Safety Issue?: No

Inclusion Criteria:

• HR+ post-menopausal patients with non-metastatic breast cancer

Exclusion Criteria:

• Any of the following: HR-, non-menopausal patient, metastatic breast cancer

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00279448

Study ID Number: EXEAPO-0028-118

ClinicalTrials.gov Identifier: NCT00279448

Health Authority: France: Afssaps - French Health Products Safety Agency

To obtain contact information for a study center near you, click here.