Ibandronate or Zoledronate in Treating Patients With Newly Diagnosed Bone Metastases From Breast Cancer - Full Text View

Sponsor:	Wales Cancer Trials Unit
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00326820

Purpose

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	Intervention	Phase
Breast Cancer Hypercalcemia of Malignancy Metastatic Cancer	Drug: ibandronate sodium Drug: zoledronic acid	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control
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 [ZICE]

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Ibandronic acid Zoledronic acid Ibandronate sodium

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Frequency and timing of skeletal-related events (SREs) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to first SREs [ Designated as safety issue: No ]
Proportion of patients with SREs [ Designated as safety issue: No ]
Pain and analgesic score [ Designated as safety issue: No ]
Quality of life [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Survival [ Designated as safety issue: No ]
Health resource usage and serum bone marker levels [ Designated as safety issue: No ]

Estimated Enrollment:	1400
Study Start Date:	January 2006
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326820

Show 79 Study Locations

Sponsors and Collaborators

Wales Cancer Trials Unit

Investigators

Study Chair:

Peter J. Barrett Lee, MD

Velindre NHS Trust

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000478864, WCTU-ZICE, NCRI-ZICE, ROCHE-ZICE, ISRCTN13914201, EU-20613, EUDRACT-2005-001710-40
Study First Received:	May 16, 2006
Last Updated:	January 5, 2010
ClinicalTrials.gov Identifier:	NCT00326820 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

hypercalcemia of malignancy
stage IV breast cancer
bone metastases
recurrent breast cancer
male breast cancer

Additional relevant MeSH terms:

Metabolic Diseases
Zoledronic acid
Skin Diseases
Physiological Effects of Drugs
Hypercalcemia
Breast Neoplasms
Bone Density Conservation Agents
Pharmacologic Actions
Calcium Metabolism Disorders

Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Ibandronic acid
Neoplasm Metastasis
Water-Electrolyte Imbalance
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010