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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Velindre NHS Trust
Information provided by (Responsible Party):
Wales Cancer Trials Unit
ClinicalTrials.gov Identifier:
NCT00326820
First received: May 16, 2006
Last updated: March 12, 2013
Last verified: March 2013

May 16, 2006
March 12, 2013
January 2006
December 2012   (final data collection date for primary outcome measure)
Frequency and timing of skeletal-related events (SREs) [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00326820 on ClinicalTrials.gov Archive Site
  • Time to first SREs [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with SREs [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]
  • Pain and analgesic score [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Health resource usage and serum bone marker levels [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Ibandronate or Zoledronate in Treating Patients With Newly Diagnosed Bone Metastases From Breast Cancer
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Hypercalcemia of Malignancy
  • Metastatic Cancer
  • Drug: ibandronate sodium
  • Drug: zoledronic acid
  • Drug: Zolendronic Acid
    Zoledronic acid 4 mg by intravenous infusion every 4 weeks.
    Other Name: Zoledronate
  • Experimental: Ibandronic Acid
    50mg tablet once daily over 96 weeks
    Intervention: 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
    Interventions:
    • Drug: zoledronic acid
    • Drug: Zolendronic Acid
Barrett-Lee P, Casbard A, Abraham J, Hood K, Coleman R, Simmonds P, Timmins H, Wheatley D, Grieve R, Griffiths G, Murray N. Oral ibandronic acid versus intravenous zoledronic acid in treatment of bone metastases from breast cancer: a randomised, open label, non-inferiority phase 3 trial. Lancet Oncol. 2014 Jan;15(1):114-22. doi: 10.1016/S1470-2045(13)70539-4. Epub 2013 Dec 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1404
October 2015
December 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00326820
CDR0000478864, WCTU-ZICE, NCRI-ZICE, ROCHE-ZICE, ISRCTN13914201, EU-20613, EUDRACT-2005-001710-40
Yes
Wales Cancer Trials Unit
Wales Cancer Trials Unit
Velindre NHS Trust
Study Chair: Peter J. Barrett Lee, MD Velindre NHS Trust
Wales Cancer Trials Unit
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP