NIPH Clinical Trials Search

UMIN ID: UMIN000000818

Registered date:05/09/2007

Randomized Study to Assess the Efficacy of a Further 5 Years of Anastrozole Treatment for Postmenopausal Women with Breast Cancer Completing 5 Years Anastrozole Containing Adjuvant Endocrine Therapy

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedHormone-responsive postmenopausal primary breast cancer
Date of first enrollment2007/11/19
Target sample size2500
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)CONTINUE arm: continuation of Anastrozole for 5 years (1 mg/day po QD) STOP arm: no-treatment (no additional medication) for 5 years


Primary OutcomeDisease-Free Survival
Secondary OutcomeOverall Survival Distant Disease-Free Survival Adverse Events Health Related Quality of Life: HRQOL Cost-Effectiveness (QALY)

Key inclusion & exclusion criteria

Age minimum45years-old
Age maximum80years-old
Include criteria
Exclude criteria1)Metachronous or synchronous bilateral breast cancer. 2)Invasive carcinoma of other organs(less than 5 years after the last treatment). 3)History of deep venous embolism. 4)History of bone fracture resulted from osteoporosis, and symptom at the randomization. 5)Taking hormone replacement therapy or selective estrogen receptor. 6)Active participant in any other clinical trial. 7)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 Takuji Iwase
Address 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan Japan
Telephone 03-3520-0111
E-mail no@mail
Affiliation The Cancer Institute Hospital of JFCR(Japanese Foundation for Cancer Research) Breast Oncology Center