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Ibandronate or Zoledronate in Treating Patients With Newly Diagnosed Bone Metastases From Breast Cancer

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ClinicalTrials.gov Identifier: NCT00326820
Recruitment Status : Unknown
Verified March 2013 by Wales Cancer Trials Unit.
Recruitment status was:  Active, not recruiting
First Posted : May 17, 2006
Last Update Posted : March 13, 2013
Sponsor:
Collaborator:
Velindre NHS Trust
Information provided by (Responsible Party):
Wales Cancer Trials Unit

Study Description
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Brief Summary:

RATIONALE: Ibandronate and zoledronate may help relieve some of the symptoms caused by bone metastases. It is not yet know whether ibandronate is more effective than zoledronate in treating bone metastases from breast cancer.

PURPOSE: This randomized phase III trial is studying ibandronate to see how well it works compared with zoledronate in treating patients with newly diagnosed bone metastases from breast cancer.


Condition or disease Intervention/treatment Phase
Breast Cancer Hypercalcemia of Malignancy Metastatic Cancer Drug: ibandronate sodium Drug: zoledronic acid Drug: Zolendronic Acid Phase 3

Detailed Description:

OBJECTIVES:

Primary

  • Compare the efficacy, in terms of reducing frequency and timing of skeletal-related events (SREs), of ibandronate vs zoledronate in patients with newly diagnosed bone metastases secondary to breast cancer.

Secondary

  • Compare the median time to first SRE in patients treated with these regimens.
  • Compare the percentage of patients experiencing a SRE after treatment with these regimens.
  • Compare the number of occult vertebral fractures present in patients at the end of treatment with these regimens.
  • Compare the pain and analgesic scores and quality of life of patients treated with these regimens.
  • Compare the number of patients developing renal dysfunction or hypocalcemia during the study period.
  • Compare the number of patients developing osteonecrosis of the jaw during study treatment and follow-up.
  • Compare the overall survival of these patients at 96 weeks and at 5 years.
  • Compare the health-resource usage of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, parallel-group, controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive zoledronate IV over 15 minutes on day 1. Treatment repeats every 21* or 28 days for at least 96 weeks (24 or 32 courses) in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients who receive concurrent chemotherapy every 3 weeks receive study treatment every 21 days

  • Arm II: Patients receive oral ibandronate once daily on days 1-28. Treatment repeats every 28 days for at least 96 weeks (24 courses) in the absence of disease progression or unacceptable toxicity. Patients with bone pain or hypercalcemia at study entry or those who require IV therapy due to hypercalcemia while on study may receive 1 treatment with ibandronate IV at the discretion of the supervising clinician.

Quality of life and pain are assessed at baseline, after every 3 courses, and at completion of study treatment.

After completion of study treatment, patients are followed annually for up to 3 years.

PROJECTED ACCRUAL: A total of 1,400 patients will be accrued for this study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Zoledronate Versus Ibandronate Comparative Evaluation: A Randomized Phase III, Open-Label, Multicenter, Parallel Group Clinical Trial to Evaluate and Compare the Efficacy, Safety Profile and Tolerability of Oral Ibandronate Versus Intravenous Zoledronate in the Treatment of Breast Cancer Patients With Bone Metastases
Study Start Date : January 2006
Actual Primary Completion Date : December 2012
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ibandronic Acid
50mg tablet once daily over 96 weeks
 Drug: ibandronate sodium
Active Comparator: Zoledronic Acid
4 mg via intravenous infusion (iv) over a minimum of 15 minutes in at least 100mls of saline every 4 weeks over 96 weeks
 Drug: zoledronic acid
Drug: Zolendronic Acid
Zoledronic acid 4 mg by intravenous infusion every 4 weeks.
Other Name: Zoledronate


Outcome Measures
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Primary Outcome Measures :
  1. Frequency and timing of skeletal-related events (SREs) [ Time Frame: 96 weeks ]

Secondary Outcome Measures :
  1. Time to first SREs [ Time Frame: 96 Weeks ]
  2. Proportion of patients with SREs [ Time Frame: 96 Weeks ]
  3. Pain and analgesic score [ Time Frame: 96 weeks ]
  4. Quality of life [ Time Frame: 96 weeks ]
  5. Toxicity [ Time Frame: 96 weeks ]
  6. Survival [ Time Frame: 5 years ]
  7. Health resource usage and serum bone marker levels [ Time Frame: 96 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven breast cancer

    • Metastatic disease
    • Previous relapsed disease in sites other than bone allowed

  • Newly diagnosed multiple bone metastases within the past 3 months, meeting all of the following criteria:

    • Painful or asymptomatic
    • Lytic, mixed, or purely sclerotic type
    • Radiological diagnosis
    • IV bisphosphonate therapy indicated
  • No CNS metastases
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Male or female
  • Menopausal status not specified
  • No known active peptic ulcer
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No active dental problems, including infection of the teeth or jawbone (maxilla or mandible) or dental or fixture trauma
  • No prior or current diagnosis of osteonecrosis of the jaw, exposed bone in the mouth, or slow healing after dental procedures
  • Creatinine clearance ≥ 30 mL/min
  • Bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • AST and ALT ≤ 1.5 times ULN
  • No history of bisphosphonate hypersensitivity
  • Able to comply with instructions relating to oral study medications
  • Able to take oral study medications
  • No psychiatric illness or other condition that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

  • At least 6 months since prior bisphosphonate therapy

  • At least 6 weeks since prior and no concurrent dental or jaw surgery (e.g., extractions or implants)

    • Concurrent unplanned dental extractions allowed provided study medication is discontinued for 8 weeks before and after the surgery
  • Concurrent chemotherapy and/or hormone therapy for metastatic disease allowed
  • No concurrent medications that affect bone metabolism (e.g., calcitonin or other nontrial bisphosphonates)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326820


Locations
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Sponsors and Collaborators
Wales Cancer Trials Unit
Velindre NHS Trust
Investigators
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Study Chair: Peter J. Barrett Lee, MD Velindre NHS Trust
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wales Cancer Trials Unit
ClinicalTrials.gov Identifier: NCT00326820    
Other Study ID Numbers: CDR0000478864
WCTU-ZICE
NCRI-ZICE
ROCHE-ZICE
ISRCTN13914201
EU-20613
EUDRACT-2005-001710-40
First Posted: May 17, 2006    Key Record Dates
Last Update Posted: March 13, 2013
Last Verified: March 2013
Keywords provided by Wales Cancer Trials Unit:
hypercalcemia of malignancy
stage IV breast cancer
bone metastases
recurrent breast cancer
male breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Neoplasms
Hypercalcemia
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
 Pathologic Processes
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Zoledronic Acid
Ibandronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs