Evaluation of Effects of Postoperative Adjuvant Therapy with Anastrozole on Bone in Postmenopausal Women with Breast Cancer

UMIN ID: UMIN000000514

Registered date:06/11/2006

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Hormone-responsive postmenopausal breast cancer
• Date of first enrollment: 2006/02/01
• Target sample size: 350
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): All study subjects in the adjuvant therapy setting are administrated Anastrozole 1mg/day p.o. for 5years. Bisphosphonate is prescribed to the subjects who has the low BMD score (<=70%).

Outcome(s)

• Primary Outcome: Incidence of bone fracture
• Secondary Outcome: 1. Incidence of bone fracture in anastrozole therapy combined with alendronate sodium hydrate 2. BMD change in anastrozole alone 3. Body Mass Index (BMI) 4. Safety

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Female
• Exclude criteria: 1. Active multiple cancer (simultaneous multiple cancer, and multi-organ invasive cancer with less than 5years of event-free survival) 2. Non-invasive cancer, inflammatory breast cancer 3. Patients with history of osteoporosis or BMD is osteoporosis level (less than 70% of young adult mean (YAM)) 4. Patients being treated with bisphosphonate drugs or other osteoporotic drugs 5. Patients diagnosed as having a history of spinal fracure in X-ray or other imagin tests 6. Serious complications (hepatic, renal, cardiac, and endocrine diseases, etc.) 7. Patients with a history of hypersensitivity to any of the ingredients of the study drug 8. Patients judged to be ineligible for participating in the study by investigators

Related Information

• Primary Sponsor: Saitama Breast Cancer Clinical Study Group (SBCCSG)
• Source(s) of Monetary Support: None