Zoledronate in Treating Osteopenia or Osteoporosis in Postmenopausal Women Receiving Letrozole for Stage I, Stage II, or Stage IIIA Primary Breast Cancer
This trial is active, not recruiting.
|Conditions||breast cancer, osteoporosis|
|Treatments||zoledronic acid, letrozole as adjuvant therapy|
|Collaborator||National Cancer Institute (NCI)|
|Start date||April 2006|
|End date||June 2008|
|Trial size||60 participants|
|Trial identifier||NCT00436917, 2330-05, MC05C8, P30CA015083|
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.
|Intervention model||single group assignment|
|Primary purpose||supportive care|
Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD)
time frame: Baseline and 1 year
Total Lumbar Spine BMD as Measured by DXA at Baseline and at 24, 36, 48, and 60 > Months
time frame: 5 yr
Femoral Neck BMD as Measured by DXA at Baseline and at 12, 24, 36, 48, and 60 Months
time frame: 5 yr
Frequency and Severity of Toxicity as Assessed by NCI CTCAE v3.0
time frame: 5 yr
Time to Disease Progression
time frame: 5 yr
Female participants at least 18 years old.
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
|Official title||Zoledronic Acid for Treatment of Osteopenia and Osteoporosis in Women With Primary Breast Cancer Undergoing Adjuvant Aromatase Inhibitor (Letrozole) Therapy|
|Principal investigator||Charles L. Loprinzi, MD|
|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.|
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