Postmenopausal Breast Cancer
Conditions
Interventions
All patients receive letrozole 2.5 mg orally daily for 5 years or until disease progression.
Patients receive zoledronic acid 4mg or an adjusted dose based on renal function IV over 15 minutes infusio
Sponsors
Cancer Institute Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Adequately diagnosed and treated invasive breast cancer defined as: 1.Clinical stage I,II or IIIA 2.Patients with breast cancer whose tumor were removed by an appropriate surgical procedure such as mastectomy or breast conserving surgery 2) ER and/or 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)Patients with a baseline lumbar spine BMD of YAM -2.0SD or more 5)Patients who have no lumbar spine and total hip fracture 6)ECOG Performance status of 0 to 2 7)Adequate organ function 8)The date of randomization must be within 12 weeks from completion of surgery or from completion of adjuvant chemotherapy. (Completion of chemotherapy is defined as completion of the last full course including recovery time) 9)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 10)A written informed consent is obtained
Exclusion criteria
Exclusion criteria: 1)Patients with any clinical or radiological evidence of distant spread of their disease at any point before randomization 2)Patients with invasive bilateral breast cancer 3)Patients who have started adjuvant endocrine therapy 4)Patients who have received any endocrine therapy within the past 12 months 5)Patients who have received prior treatment with intravenous bisphosphonates within the past 12 months 6)Patients with the following diseases which may interfere with DXA scan: severe scoliosis, immobility, hyperosteosis or sclerotic changes at the lumbar spine, calcification of abdominal aorta, vertebral diseases 7)Patients with previous or concomitant malignancy (not breast cancer) within the past 5 years 8)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) 9)Other conditions judged as inappropriate for the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the percent change in the lumbar spine(L1-L4)BMD, as measured by DXA, at 12 months in postmenopausal women with hormone receptor-positive breast cancer randomized to zoledronic acid upfront versus delayed start. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)To compare the percent change in lumbar spine(L1-L4)BMD at two years, three years, four years and five years between the two treatment groups. 2)To compare the percent change in total hip BMD at 12 months, two years, three years, four years and five years between the two treatment groups. 3)To identify changes in serum markers of bone turnover, serum NTX and BSAP, at 12 months, two years, three years, four years and five years. 4)To compare the incidence rate of all clinical fractures at three years between the two treatment groups. 5)To compare the profile of serum lipids. 6)To compare the time to disease progression between the two treatment groups. 7)To compare the overall survival between the two treatment groups. 8)Adverse events | — |
Countries
Japan
Contacts
Public ContactShunji Takahashi
Cancer Institute Hospital Division of Medical Oncology
Outcome results
None listed