Zoledronate in Treating Osteopenia or Osteoporosis in Postmenopausal Women Receiving Letrozole for Stage I, Stage II, or Stage IIIA Primary Breast Cancer

• Status: Completed
• Trial end date: 2016-05-09
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Diphosphonates; Letrozole; Zoledronic Acid

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