breast cancer
Conditions
Interventions
Sponsors
Kyoto Prefectural Universuty of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Adequately diagnosed and treated invasive breast cancer defined as 1.Clinical stage 1,2 or 3a 2.Patients with breast cancer whose tumor were removed by an appropriate surgical procedure such as mastectomy or breast conserving surgery 2) ER and PgR positive defined with immunohistochemical staining 3) Postmenopausal status defined by one of the following 1.women >54 years with cessation of menses 2.spontaneous cessation of menses within the past 1 years, but amenorrheic in women <55 years, and according to the definition of 'postmenopausal range' for FSH and estradiol level 3.bilateral oophorectomy 4) Lumbar spine, total hip or femoral neck BMD equivalent to a YAM classification of less than -2.5 5) ECOG Performance status of 0 to 2 6) Patients who have completed chemothrapy >4 weeks prior to study entry 7) Patients who have discontinued the following drugs known as affect to the skeleton more than 4 weeks oral bisphosphonates, estrogen, raloxifene, calcitonin, vitamin K, activated vitamin D, ipriflavone 8) A written informed consent is obtained
Exclusion criteria
Exclusion criteria: 1) Diagnosis of clinical or radiological disant metastasis before inclusion 2) Invasive bilateral breast cancer 3) Received prior treatment with intravenous bisphosphonates within the past 12 months 4) Following diseases which may interfere with DXA scan such as severe scoliosis, vertebral diseases 5) Current active dental problems including infection of the teeth or jawbone. Recent (within 6 weeks) or planned dental or jaw surgery(e.g., extraction, implants) 6) Other conditions judged as inappropriate for the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the percent change in lumbar spine(L1-L4)BMD from baseline to 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) the percent change in lumbar spine(L1-L4)BMD from basebaline to 6 months,two years, three years, four years and five years. 2) the percent change in total hip BMD from basebaline to 6 months, 12 months, two years, three years, four years and five years. 3) To identify changes in serum markers of bone turnover, TRACP-5b and BAP, from basebaline to 6 months, 12 months, two years, three years, four years and five years. 4) Disease-free survival 5) Bone metastasis-free survival 6) Overall survival 7) Distant recurrence-free survival | — |
Countries
Japan
Contacts
Public Contactyoshimi ouchi
Kyoto Prefectural Universuty of Medicine Department of Endocrine and Breast Surgery
Outcome results
None listed