Hormone-responsive postmenopausal breast cancer
Conditions
Interventions
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%).
Sponsors
Saitama Breast Cancer Clinical Study Group (SBCCSG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Primary breast cancer in TNM tumor stage I,II or IIIA 2. Patients who underwent mastectomy or breast conserving surgery 3. Postmenopausal women who meet any of the following criteria No menstruation for more than one year, or 60 years or over, Postmenopausal levels of follicle-stimulating hormone (FSH) and estradiol (E2), or Bilateral ovariectomy 4. ER and/or PgR-positive primary tumor 5. Adequate renal, hepatic and cardiac function 6. Performance status (PS), (ECOG):0-1 7. Written informed consent was obtained from a patient
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of bone fracture | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactToshihiro Kai
Saitama Breast Cancer Clinical Study Group; SBCCSG in Omiya Kyoritsu Hospital Surgery
Outcome results
None listed