NIPH Clinical Trials Search

UMIN ID: C000000056

Registered date:12/08/2005

Phase III Randomized Adjuvant Study of Tamoxifen Alone Versus Sequential Tamoxifen and Anastrozole 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 enrollment2002/11/01
Target sample size2500
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)TAM:Tamoxifen alone (total 5 years) ANA:Sequential Tamoxifen and Anastrozole (change after registration, total 5 years)


Primary OutcomeDisease-Free Survival Adverse Events
Secondary OutcomeRelapse-Free Survival Overall Survival Health-Related QOL Efficacy of medical economy

Key inclusion & exclusion criteria

Age minimum65years-old
Age maximumNot applicable
Include criteria
Exclude criteria(1)Invasive carcinoma of other organs (less than 5years after the last treatment) (2)Metachronous or synchronous bilateral breast cancer (3)Past deep venous embolism (4)Osteoporosis needed to be treated or past bone fracture because of osteoporosis (5)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 Tomohiko Aihara
Address 3-3-20, Makiochi, Minoo-shi, Osaka, 562-0004, Japan Japan
Telephone 072-723-9001
E-mail no@mail
Affiliation Aihara Hospital Department of Breast