Breast Cancer Clinical Trial
Zoledronate in Treating Osteopenia or Osteoporosis in Postmenopausal Women Receiving Letrozole for Stage I, Stage II, or Stage IIIA Primary Breast Cancer
Summary
RATIONALE: Zoledronate may reduce bone loss in patients receiving letrozole for breast cancer.
PURPOSE: This clinical trial is studying how well zoledronate works in treating osteopenia or osteoporosis in postmenopausal women receiving letrozole for stage I, stage II, or stage IIIA primary breast cancer.
Full Description
OBJECTIVES:
Primary
Assess changes in total lumbar spine bone mineral density (BMD) from baseline to 12 months in postmenopausal women treated with zoledronate for osteopenia or osteoporosis and letrozole for hormone receptor-positive, stage I-IIIA primary breast cancer.
Secondary
Determine changes in total lumbar spine BMD from baseline to 2, 3, 4, and 5 years in these patients.
Determine changes in femoral neck BMD from baseline to 1, 2, 3, 4, and 5 years in these patients.
Determine time to disease progression in these patients.
OUTLINE: This is an open-label, multicenter study.
Adjuvant aromatase inhibitor therapy: Patients receive oral letrozole daily for up to 5 years in the absence of disease progression or unacceptable toxicity.
Osteoporosis management: Patients receive zoledronate IV over 15 minutes on day 1. Patients also receive oral elemental calcium twice daily and oral vitamin D daily for 6 months. Treatment repeats every 6 months for up to 5 years in the absence of disease progression or unacceptable toxicity.
Patients undergo total lumbar spine and hip (femoral neck) bone density testing by dual energy x-ray absorptiometry (DXA) at baseline and annually for 5 years.
After completion of study therapy, patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of localized breast cancer
Stage I-IIIA disease
Adequately treated breast cancer
No clinical or radiological evidence of recurrent or metastatic disease
Baseline total lumbar spine or femoral neck bone mineral density T-score < -2.0 standard deviation (e.g., a patient with a T score of -2.1 is eligible)
Hormone-receptor status:
Estrogen receptor and/or progesterone receptor-positive breast cancer
PATIENT CHARACTERISTICS:
Female
Postmenopausal, defined by 1 of the following criteria:
Age > 55 years with cessation of menses
Age ≤ 55 years with spontaneous cessation of menses for > 1 year
Age ≤ 55 years with spontaneous cessation of menses for ≤ 1 year, but amenorrheic (e.g., spontaneous or secondary to hysterectomy), AND has postmenopausal estradiol levels
Bilateral oophorectomy
ECOG performance status 0-2
Life expectancy ≥ 5 years
WBC ≥ 3,000/mm³ OR granulocyte count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)
AST ≤ 3 times ULN
Creatinine < 2.0 mg/dL
Creatinine clearance ≥ 45 mL/min
No hypercalcemia (i.e., calcium level > 1 mg/dL above ULN) OR hypocalcemia (i.e., calcium level > 0.5 mg/dL below lower limit of normal) within the past 6 months
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
No other nonmalignant systemic diseases, including any of the following:
Uncontrolled infection
Uncontrolled diabetes mellitus
Uncontrolled thyroid dysfunction
Disease affecting bone metabolism (hyperparathyroidism, hypercortisolism, Paget's disease, osteogenesis imperfecta)
Malabsorption syndrome
No uncontrolled seizure disorders associated with falls
No known hypersensitivity to zoledronate or other bisphosphonates, letrozole, calcium, or vitamin D
No concurrent active dental problems, including any of the following:
Infection of the teeth or jawbone (maxillary or mandibular)
Dental or fixture trauma
Prior or current diagnosis of osteonecrosis of the jaw
Exposed bone in the mouth
Slow healing after dental procedures
No contraindication to spine dual energy x-ray absorptiometry (DXA) as defined by any of the following:
History of surgery at the lumbosacral spine, with or without implantable devices
Scoliosis with a Cobb angle > 15 degrees at the lumbar spine
Immobility, hyperostosis, or sclerotic changes at the lumbar spine, or evidence of sclerotic abdominal aorta sufficient to interfere with DXA scan
Disease of the spine that would preclude the proper acquisition of a lumbar spine DXA
No condition that would preclude study follow-up or compliance
No psychiatric illness that would preclude giving informed consent
PRIOR CONCURRENT THERAPY:
More than 3 weeks since prior and no other concurrent oral bisphosphonates
No prior intravenous bisphosphonates
No prior aromatase inhibitor therapy
More than 6 months since prior anabolic steroids or growth hormone
More than 2 weeks since prior and no concurrent inhibitor of osteoclastic bone resorption (e.g., calcitonin, mithramycin, or gallium nitrate)
More than 30 days since prior systemic investigational drug and/or device
More than 7 days since prior topical investigational drug
More than 6 weeks since prior and no concurrent dental or jaw surgery (e.g., extraction, implants)
Concurrent short-term corticosteroid therapy allowed
No concurrent sodium fluoride, parathyroid hormone, or tibolone
No other concurrent investigational drug or device
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There are 2 Locations for this study
Jacksonville Florida, 32224, United States
Rochester Minnesota, 55905, United States
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