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

Pfizer9,779 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

9,779

Conditions

Breast Neoplasms

Interventions

exemestane (Aromasin)DRUG

exemestane, orally, 25 mg, for 5 years

tamoxifen + exemestaneDRUG

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

Eligibility

Sex: FEMALEMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (179)

Outcomes

Primary Outcomes

Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline 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.

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

Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline 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.

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

Secondary Outcomes

Number of Events for Overall Survival (OS)

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 frame: Baseline (Month 0) up to 5 years

Time to New Primary Breast Cancers

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

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

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Bessemer, Alabama, United States

Pfizer Investigational Site