NIPH Clinical Trials Search

UMIN ID: C000000057

Registered date:12/08/2005

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedhormone-responsive postmenopausal primary breast cancer
Date of first enrollment2003/09/01
Target sample size300
Countries of recruitmentJapan
Study typeInterventional
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


Primary OutcomeRelapse-Free Survival after a lapse of 2.5-3 years Quantity of lipid metabolic Bone mineral content
Secondary OutcomeRelapse-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 minimum60years-old
Age maximumNot applicable
Include criteria
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


public contact
Name Akira Yamao
Address 1-1-7, Nishiwaseda, Shinjyuku-ku, Tokyo, 169-0051 JAPAN Japan
Telephone 03-5287-2633
Affiliation Public Health Research Foundation Comprehensive Support Project for Clinical Research
scientific contact
Name Yasuo Hozumi
Address 3311-1, Yakushiji, Minamikouchi-cho, Kouchi-gun, Tochigi, 329-0498, Japan Japan
Telephone 0285-58-7371
E-mail no@mail
Affiliation Jichi Medical School Department of Mammary gland/General Surgery