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Exemestane As Treatment In Adjuvant For Post-Menopausal Patients With Non-Metastatic Breast Cancer (TEAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00279448
Recruitment Status : Completed
First Posted : January 19, 2006
Last Update Posted : December 23, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:

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


Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: exemestane Drug: tamoxifen Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9779 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2002
Actual Primary Completion Date : November 2008
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: A Drug: exemestane
On tablet of 25 mg per day during 5 years
Other Name: Aromasin
Active Comparator: B 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
Other Name: Kessar


Outcome Measures
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Primary Outcome Measures :
  1. To compare recurrence free survival between two treatment groups. [ Time Frame: 2.75 years and 5 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. Overall survival between the 2 treatment groups [ Time Frame: Every 3 months during first year then every 6 months for 4 years ]
  3. 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 ]
  4. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Any of the following: HR-, non-menopausal patient, metastatic breast cancer
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279448


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00279448    
Other Study ID Numbers: EXEAPO-0028-118
A5991081
First Posted: January 19, 2006    Key Record Dates
Last Update Posted: December 23, 2011
Last Verified: December 2011
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Exemestane
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action