S0308 Zoledronate or Ibandronate in Preventing Bone Problems in Women With Stage IV Breast Cancer That Has Spread to the Bone

• Status: Withdrawn
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Zoledronate and ibandronate may prevent or help relieve bone pain and other symptoms caused by bone metastases. It is not yet known whether zoledronate is more effective than ibandronate in preventing bone problems caused by bone metastases due to breast cancer.

PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to ibandronate in preventing bone problems in women with stage IV breast cancer that has spread to the bone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Diphosphonates; Ibandronic Acid; Zoledronic Acid

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage IV breast cancer at primary diagnosis or at recurrence

• Any T, any N, M1

• At least 1 dominant osteolytic or osteoblastic or mixed metastatic lesion outside any prior radiation field

• Lesion measures ≥ 1.0 cm by x-ray, CT scan, and/or MRI

• Controlled asymptomatic brain metastases allowed

• Controlled bone pain, defined as a physician/health care provider rating of ≤ grade 2 pain-SELECT (Bone) on the NCI CTC for Adverse Events Version 3.0 rating scale, required

• Current evidence of vertebral or nonvertebral fractures or spinal compression due to cancer, as determined by the treating physician, allowed

• No Paget's disease of the bone

• Estrogen receptor (ER) or progesterone receptor (PR) status known

PATIENT CHARACTERISTICS:

• Female patient

• Menopausal status not specified

• Zubrod performance status 0-2

• Creatinine normal

• Creatinine clearance ≥ 60 mL/min

• Serum calcium < 12 mg/dL

• Not pregnant or nursing

• Fertile patients must use effective contraception

• Must be able to receive IV medication and oral medication (i.e., must have physical integrity of the upper gastrointestinal tract)

• No malabsorption syndrome

• No primary hyperparathyroidism

• No known history of aspirin-sensitive asthma

• No other prior malignancy except for the following:

• Adequately treated basal cell or squamous cell skin cancer

• In situ cervical cancer

• Adequately treated stage I or II cancer currently in complete remission

• Any other cancer for which the patient has been disease-free for at least 5 years

• No uncontrolled medical illness or infection, including, but not limited to, the following:

• Unstable angina

• Recent myocardial infarction

• Life-threatening cardiac arrhythmia

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior bisphosphonates for metastatic bone disease

• More than 28 days since prior aminoglycoside antibiotics

• At least 28 days since prior oral bisphosphonates for osteoporosis

• More than 6 months since prior bisphosphonates used for adjuvant therapy

• Concurrent treatment, including chemotherapy, hormonal therapy, and/or biologic therapy for metastatic breast cancer allowed

• No concurrent participation in another clinical treatment trial for this cancer unless the patient is no longer receiving the intervention and is in the follow-up phase of the other clinical trial