S0308 Zoledronate or Ibandronate in Preventing Bone Problems in Women With Stage IV Breast Cancer… (NCT00301886) | Clinical Trial Compass
WithdrawnPhase 3
S0308 Zoledronate or Ibandronate in Preventing Bone Problems in Women With Stage IV Breast Cancer That Has Spread to the Bone
Stopped: withdrawn support for study
0Started 2006-05
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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 complet…