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”

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.

Study Type: Interventional

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

Study Primary Completion Date: November 2008

Intervention(s) in this Clinical Trial

• Drug: exemestane (Aromasin)
  • exemestane, orally, 25 mg, for 5 years
• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: exemestane
• Experimental: tamoxifen + exemestane

Primary 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
    Safety Issue?: No
• Disease Free Survival
  • Time Frame: 5 years
    Safety Issue?: No

Secondary Measures

• Overall Survival
  • Time Frame: 5 years
    Safety Issue?: No
• The Incidence of New Primary Breast Cancers of the Postmenopausal Women Treated With 5 Years of Exemestane (Aromasin) Versus Tamoxifen Therapy for 2.5- 3 Years Followed by 2.5- 2 Years of Exemestane (Aromasin).
  • Time Frame: 2.75 years; 5 years
    Safety Issue?: No
• Summary of Adverse Events: Overall Number of Subjects Affected for Adverse Events and Serious Adverse Events
  • Time Frame: Baseline up to 5 years
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on March 18, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00036270

Study ID Number: 971-ONC-0028-081

ClinicalTrials.gov Identifier: NCT00036270

Health Authority: United States: Food and Drug Administration

To obtain contact information for a study center near you, click here.

Link to NCT00279448 (France Study Data Included)

Link to ClinicalStudyResults.org Posting