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

UMIN ID: UMIN000000818

Registered date:05/09/2007

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: 2007/11/19
• Target sample size: 2500
• Countries of recruitment: Japan
• Study type: Interventional

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

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: 45years-old
• Age maximum: 80years-old
• Gender: Female
• Exclude criteria: 1)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

• Primary Sponsor: AERAS executive committee
• Source(s) of Monetary Support: Public Health Research Foundation