Exemestane As Treatment In Adjuvant For Post-Menopausal Patients With Non-Metastatic Breast Cancer

Pfizer9,779 enrolled

Overview

To compare recurrence free survival between two treatment groups (5 years with exemestane vs 2.5 to 3 years tamoxifen followed by 2 to 2.5 years of exemestane for a total duration of 5 years) 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. Link to TEAM Trial \[971-ONC-0028-081/A5991026\] Study Results: http://clinicaltrials.gov/ct2/show/results/NCT00036270?term=971-ONC-0028-081\&rank=1

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

9,779

Conditions

Breast Neoplasms

Interventions

On tablet of 25 mg per day during 5 years

tamoxifenDRUG

Two tablets of tamoxifen 10 mg per day during 2.5 to 3 years followed by one tablet of exemestane 25 mg per day during 2 to 2.5 years for a total duration of 5 years of treatment

Eligibility

Sex: FEMALEMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * HR+ post-menopausal patients with non-metastatic breast cancer Exclusion Criteria: * Any of the following: HR-, non-menopausal patient, metastatic breast cancer

Locations (59)

Pfizer Investigational Site

Marseille, Be1 01971, France

Pfizer Investigational Site

Compiègne, Be1 02256, France

Pfizer Investigational Site

Rennes, Be1 03677, France

Pfizer Investigational Site

Brest, Be1 04292, France

Pfizer Investigational Site

Aix-en-Provence, France

Pfizer Investigational Site

Outcomes

Primary Outcomes

To compare recurrence free survival between two treatment groups.

Time frame: 2.75 years and 5 years

Secondary Outcomes

The quality of life of patients treated with exemestane to that of patients treated with tamoxifen

Time frame: Every 3 months during first year then every 6 months for 4 years

Overall survival between the 2 treatment groups

Time frame: Every 3 months during first year then every 6 months for 4 years

Incidence of a second breast cancer (contralateral) between the 2 treatment groups

Time frame: Every 3 months during first year then every 6 months for 4 years

General tolerance in the short- and long-term between the 2 treatment groups

Time frame: Every 3 months during first year then every 6 months dor 4 years

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Annecy, France

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Avignon, France

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Bayonne, France

Pfizer Investigational Site

Blois, France

...and 49 more locations