Phase III Randomized Adjuvant Study of Exemestane Versus Anastrozole Versus Tamoxifen in Hormone-Responsive Postmenopausal Breast Cancer Patients

UMIN ID: C000000057

Registered date:12/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: hormone-responsive postmenopausal primary breast cancer
• Date of first enrollment: 2003/09/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

EXE : Exemestane for 5 years
TAM : Tamoxifen for 2.5-3 years followed by Exemestane for 2.5-3 years (control)
ANA : Anastrozole for 5 years

Outcome(s)

• Primary Outcome: Relapse-Free Survival after a lapse of 2.5-3 years Quantity of lipid metabolic Bone mineral content
• Secondary Outcome: Relapse-Free Survival after a lapse of 5 years Overall Survival Rate of contralateral breat cancer Adverse events Long-term tolerance Function of blood coagulation and fibrinolysis Health Related QOL

Key inclusion & exclusion criteria

• Age minimum: 60years-old
• Age maximum: Not applicable
• Gender: Female
• Exclude criteria: (1)invasive carcinoma of other organs (less than 5 years after the last treatment) (2)Past breast cancer (3)Past deep venous embolism (4)HRT(hormone replacement therapy) for symptoms of menopause within 4weeks before treatment (5)Metachronous or synchronous bilateral breast cancer (6)Patients judged inappropriate for this study by the physicians

Related Information

• Primary Sponsor: N-SAS BC 04 executive committee
• Source(s) of Monetary Support: Public Health Research Foundation