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

Phase 3

Completed

• Conditions: Breast Neoplasms
• Interventions: Drug: exemestane (Aromasin); Drug: tamoxifen + exemestane

• Registration Number: NCT00036270
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-08
• Study First Submitted: 2002-05-08
• Study First Submitted QC: 2002-05-08
• Study First Posted: 2002-05-09
• Primary Completion: 2008-10
• Results First Submitted: 2009-10-30
• Results First Submitted QC: 2009-11-02
• Results First Posted: 2009-12-04
• Study Completion: 2011-02
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-06
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 9779

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exemestane	exemestane (Aromasin)	-
tamoxifen + exemestane	tamoxifen + exemestane	-

Primary Outcome Measures

Name	Time	Method
Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years	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.
Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 5 Years	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 Outcome Measures

Name	Time	Method
Time to New Primary Breast Cancers	Baseline (Month 0) up to 5 years	New primary breast cancers were defined as events of ipsilateral/contralateral breast cancer (CBC).
Number of Events for Overall Survival (OS)	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.
Number of Events for Time to Relapse	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.
Number of Participants With New Primary Non-breast Cancers	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Vancouver, Washington, United States