Zoledronate in Preventing Bone Loss in Postmenopausal Women Who Are Receiving Letrozole for Stage I, Stage II, or Stage IIIA Breast Cancer
- Conditions
- Breast CancerOsteoporosis
- Interventions
- Registration Number
- NCT00107263
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Zoledronate may prevent bone loss in patients who are receiving letrozole. It is not yet known which schedule of zoledronate is more effective in preventing bone loss in patients with breast cancer.
PURPOSE: This randomized phase III trial is studying two different schedules of zoledronate to compare how well they work in preventing bone loss in postmenopausal women who are receiving letrozole for stage I, stage II, or stage IIIA breast cancer.
- Detailed Description
OBJECTIVES:
* Compare the effectiveness of zoledronate vs standard care in reducing bone loss during the first 12 months of study treatment in postmenopausal women with stage I-IIIA breast cancer initiating letrozole after prior treatment with tamoxifen.
* Compare the effect of immediate vs delayed zoledronate, annually at 2-5 years post-baseline, in reducing bone loss in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to duration of prior tamoxifen therapy (≤ 2 years vs \> 2 years); time since tamoxifen therapy was discontinued (\< 1 vs ≥ 1 year); prior adjuvant chemotherapy (yes vs no); and baseline total lumbar spine or femoral neck bone mineral density (BMD) T-score (\> -1 standard deviation \[SD\] vs between -1 to -2 SD). Patients are randomized to 1 of 2 treatment arms.
* Arm I (immediate therapy): Patients receive oral letrozole once daily. Patients also receive zoledronate IV over 15 minutes once every 6 months.
* Arm II (delayed therapy): Patients receive oral letrozole as in arm I. Patients with radiologic evidence of bone loss after 1 year of letrozole therapy receive zoledronate as in arm I.
In both arms, treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 550 patients (275 per treatment arm) will be accrued for this study within 28 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 558
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I: letrozole + zoledronate letrozole Patients receive oral letrozole once daily. Patients also receive zoledronate IV over 15 minutes once every 6 months. Treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity. Arm I: letrozole + zoledronate zoledronic acid Patients receive oral letrozole once daily. Patients also receive zoledronate IV over 15 minutes once every 6 months. Treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity. Arm II: letrozole + zoledronate letrozole Patients receive oral letrozole once daily. Patients with radiologic evidence of bone loss after 1 year of letrozole therapy receive zoledronate as in arm I. Treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity. Arm II: letrozole + zoledronate zoledronic acid Patients receive oral letrozole once daily. Patients with radiologic evidence of bone loss after 1 year of letrozole therapy receive zoledronate as in arm I. Treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Average intra-patient change in total lumbar spine (L1-L4) bone mineral density (BMD) as measured by dual energy x-ray absorptiometry at baseline and 1 year after completion of study treatment at 12 months
- Secondary Outcome Measures
Name Time Method BMD (lumbar spine) annually for 5 years after completion of study treatment Up to 5 years Incidence of osteoporosis Up to 5 years Loss of bone density Up to 5 years Incidence of bone fractures Up to 5 years Time to disease progression Up to 5 years