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Completed

NCT Number: NCT00279448

Exemestane As Treatment In Adjuvant For 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. 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

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Marseille, Be1 01971, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Exemestane

Drug

On tablet of 25 mg per day during 5 years

Other names: Aromasin

Tamoxifen

Drug

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 names: Kessar

Primary outcomes

  1. To compare recurrence free survival between two treatment groups.

    Time frame: 2.75 years and 5 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Acronym: TEAM

Important dates

Study start
2002
Primary completion
2008
Study completion
2009
First posted
Jan 19, 2006
Registry last updated
Dec 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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