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

Primary Purpose

Breast Cancer, Hypercalcemia of Malignancy, Metastatic Cancer

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ibandronate
zoledronate
quality-of-life assessment
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring pain, hypercalcemia of malignancy, stage IV breast cancer, bone metastases, recurrent breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    zoledronate

    ibandronate

    Arm Description

    zoledronate

    ibandronate

    Outcomes

    Primary Outcome Measures

    Skeletal-related events (SRE)

    Secondary Outcome Measures

    Change in patient's rating of worst pain as measured by the Brief Pain Inventory
    Survival and time to first clinically apparent SRE
    Tolerability and toxicity as measured by NCI CTCAE v3.0
    Changes in performance status

    Full Information

    First Posted
    March 9, 2006
    Last Updated
    November 11, 2013
    Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00301886
    Brief Title
    S0308 Zoledronate or Ibandronate in Preventing Bone Problems in Women With Stage IV Breast Cancer That Has Spread to the Bone
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    withdrawn support for study
    Study Start Date
    May 2006 (undefined)
    Primary Completion Date
    May 2006 (Actual)
    Study Completion Date
    May 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Hypercalcemia of Malignancy, Metastatic Cancer, Pain
    Keywords
    pain, hypercalcemia of malignancy, stage IV breast cancer, bone metastases, recurrent breast cancer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    zoledronate
    Arm Type
    Experimental
    Arm Description
    zoledronate
    Arm Title
    ibandronate
    Arm Type
    Experimental
    Arm Description
    ibandronate
    Intervention Type
    Drug
    Intervention Name(s)
    ibandronate
    Other Intervention Name(s)
    ibandronate sodium
    Intervention Type
    Drug
    Intervention Name(s)
    zoledronate
    Other Intervention Name(s)
    zoledronic acid
    Intervention Type
    Procedure
    Intervention Name(s)
    quality-of-life assessment
    Primary Outcome Measure Information:
    Title
    Skeletal-related events (SRE)
    Secondary Outcome Measure Information:
    Title
    Change in patient's rating of worst pain as measured by the Brief Pain Inventory
    Title
    Survival and time to first clinically apparent SRE
    Title
    Tolerability and toxicity as measured by NCI CTCAE v3.0
    Title
    Changes in performance status

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Saul E. Rivkin, MD
    Organizational Affiliation
    Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Kathy S. Albain, MD
    Organizational Affiliation
    Loyola University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Dawn Hershman, MD
    Organizational Affiliation
    Herbert Irving Comprehensive Cancer Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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

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