S0308 Zoledronate or Ibandronate in Preventing Bone Problems in Women With Stage IV Breast Cancer That Has Spread to the Bone
Information source: Southwest Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer; Hypercalcemia of Malignancy; Metastatic Cancer; Pain
Intervention: ibandronate (Drug); zoledronate (Drug); quality-of-life assessment (Procedure)
Phase: Phase 3
Status: Withdrawn
Sponsored by: Southwest Oncology Group Official(s) and/or principal investigator(s): Saul E. Rivkin, MD, Study Chair, Affiliation: Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Kathy S. Albain, MD, Study Chair, Affiliation: Loyola University Dawn Hershman, MD, Study Chair, Affiliation: Herbert Irving Comprehensive Cancer Center
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.
Clinical Details
Official title: A Phase III Randomized, Multicenter Non-Inferiority Trial Evaluating the Efficacy of Oral Ibandronate Versus Intravenous Zoledronate in the Reduction of Skeletal-Related Events in Patients With Metastatic Breast Cancer
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: Skeletal-related events (SRE)
Secondary outcome: Change in patient's rating of worst pain as measured by the Brief Pain InventorySurvival and time to first clinically apparent SRE Tolerability and toxicity as measured by NCI CTCAE v3.0 Changes in performance status
Detailed description:
OBJECTIVES:
Primary
- Compare the efficacy of zoledronate vs ibandronate, in terms of preventing the
occurrence of skeletal-related events (SRE) (e. g., fracture, spinal cord compression,
radiotherapy or surgery for bone symptoms or events, or hypercalcemia ≥ grade 3), in
women with stage IV breast cancer and bone metastases.
Secondary
- Compare the change in patient-reported measures of pain and use of analgesics in
patients treated with these drugs.
- Compare the time to first clinically apparent SRE in patients treated with these drugs.
- Compare the toxicity of these drugs.
- Compare the changes in performance status and overall survival of patients treated with
these drugs.
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to
hormone receptor status (estrogen receptor [ER] and progesterone receptor [PR] negative vs
ER and/or PR positive) and current evidence of fracture (vertebral or nonvertebral) or
spinal compression (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral ibandronate once daily on days 1-28.
- Arm II: Patients receive zoledronate IV over 15 minutes on day 1. In both arms,
treatment repeats every 28 days for up to 18 courses in the absence of unacceptable
toxicity.
Quality of life and pain are assessed at baseline, every 3 courses during study treatment,
and at the end of study treatment.
After completion of study treatment, patients are followed periodically for up to 3 years.
PROJECTED ACCRUAL: A total of 488 patients will be accrued for this study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Additional Information
Starting date: May 2006
Last updated: November 11, 2013
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