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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00279448 |
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.
Condition | Intervention | Phase |
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Breast Neoplasms |
Drug: exemestane Drug: tamoxifen |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 1379 |
Study Start Date: | January 2002 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Drug: exemestane
On tablet of 25 mg per day during 5 years
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B: Active Comparator |
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
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | EXEAPO-0028-118, A5991081 |
Study First Received: | January 17, 2006 |
Last Updated: | April 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00279448 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Estrogen Antagonists Estrogens Skin Diseases Antineoplastic Agents, Hormonal Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Adjuvants, Immunologic Breast Neoplasms Quality of Life |
Bone Density Conservation Agents Selective Estrogen Receptor Modulators Tamoxifen Hormones Estrogen Receptor Modulators Exemestane Aromatase Inhibitors Breast Diseases Menopause |
Estrogen Antagonists Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Enzyme Inhibitors Bone Density Conservation Agents |
Selective Estrogen Receptor Modulators Tamoxifen Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Exemestane Aromatase Inhibitors Breast Diseases |