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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00036270
First received: May 8, 2002
Last updated: March 27, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Drug: exemestane (Aromasin)
Drug: tamoxifen + exemestane
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Number of Events for Overall Survival (OS) [ Time Frame: Baseline (Month 0) up to 5 years ] [ Designated as safety issue: No ]
    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.

  • Time to New Primary Breast Cancers [ Time Frame: Baseline (Month 0) up to 5 years ] [ Designated as safety issue: No ]
    New primary breast cancers were defined as events of ipsilateral/contralateral breast cancer (CBC).

  • Number of Events for Time to Relapse [ Time Frame: Baseline (Month 0) up to 5 years ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With New Primary Non-breast Cancers [ Time Frame: Baseline (Month 0) up to 5 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 9779
Study Start Date: August 2001
Study Completion Date: February 2011
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: exemestane Drug: exemestane (Aromasin)
exemestane, orally, 25 mg, for 5 years
Other Name: aromasin
Experimental: tamoxifen + exemestane Drug: tamoxifen + exemestane
tamoxifen, 20 mg, orally, daily, 2-3 years; followed by exemestane, orally, 25 mg, for a total of 5 years of therapy

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00036270

  Show 179 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00036270     History of Changes
Other Study ID Numbers: 971-ONC-0028-081, A5991026
Study First Received: May 8, 2002
Results First Received: October 30, 2009
Last Updated: March 27, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Exemestane
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014