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Completed

NCT Number: NCT00036270

Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane

To compare the effects of exemestane for 5 years versus tamoxifen and exemestane given sequentially over 5 years in the adjuvant treatment of postmenopausal women with early breast cancer.

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.

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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, Bessemer, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically/cytologically confirmed adenocarcinoma of the breast, followed by adequate surgical resection and/or radiotherapy, and/or adjuvant chemotherapy, if indicated.
  • Stage T1-3 N0-2 Mo, Any TNM stage BC for whom adjuvant hormonal therapy is being considered.

Exclusion criteria

  • Those patients not deemed to have had potentially curative primary surgical treatment or one of the following criteria:
  • Inflammatory breast cancer
  • Histologically positive supraclavicular nodes
  • Ulceration/infiltration of local skin metastasis
  • Neoadjuvant chemotherapy
  • Ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) without invasion
  • ER and PR negative primary tumor or ER/PR unknown status.

Treatment and study plan

exemestane (Aromasin)

Drug

exemestane, orally, 25 mg, for 5 years

Other names: aromasin

tamoxifen + exemestane

Drug

tamoxifen, 20 mg, orally, daily, 2-3 years; followed by exemestane, orally, 25 mg, for a total of 5 years of therapy

Primary outcomes

  1. Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years

    Time frame: Baseline (Month 0) up to 2.75 years

    Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 2.75 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.

  2. Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 5 Years

    Time frame: Baseline (Month 0) up to 5 years

    Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 5 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.

Secondary outcomes

  1. Number of Events for Overall Survival (OS)

    Time frame: Baseline (Month 0) up to 5 years

    Number of events (death) to time of observation for OS. OS is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.

  2. Time to New Primary Breast Cancers

    Time frame: Baseline (Month 0) up to 5 years

    New primary breast cancers were defined as events of ipsilateral/contralateral breast cancer (CBC).

  3. Number of Events for Time to Relapse

    Time frame: Baseline (Month 0) up to 5 years

    Number of events to time of observation for relapse. Relapse is defined as all recurrences of the primary tumor (loco-regional and distant recurrence), second primary breast cancer, contralateral breast cancer.

  4. Number of Participants With New Primary Non-breast Cancers

    Time frame: Baseline (Month 0) up to 5 years

    Number of participants with new primary non-breast cancers which included colorectal cancer, lung cancer, endometrial cancer, ductal carcinoma in situ (DCIS) and other primary cancer types.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen For 2.5- 3 Years Followed By Exemestane (Aromasin) For A Total Of 5 Years As Adjuvant Therapy For Postmenopausal, Receptor Positive, Node Negative or Node Positive Breast Cancer Patients

Acronym: TEAM

Important dates

Study start
2001
Primary completion
2008
Study completion
2011
First posted
May 9, 2002
Registry last updated
Oct 28, 2015

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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