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Clinical Trials/ISRCTN29188871
ISRCTN29188871
Completed
Phase 2

A phase II, double blind, randomised, dose ranging, safety and efficacy trial of rapid intravenous infusion of Zoledronate versus Aredia in breast cancer patients with osteolytic metastases

Cancer Research UK (CRUK) (UK)0 sites0 target enrollmentAugust 19, 2002
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ConditionsBreast cancerCancer

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Breast cancer
Sponsor
Cancer Research UK (CRUK) (UK)
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 19, 2002
End Date
January 31, 1998
Last Updated
6 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Cancer Research UK (CRUK) (UK)

Eligibility Criteria

Inclusion Criteria

  • •1\. Aged \>18 years
  • •2\. Histologically confirmed diagnosis of breast cancer
  • •3\. At least one osteolytic lesion which measures at least 1 cm in diameter which has not been treated with radiation therapy in the 3 months prior to the start of treatment
  • •4\. Metastatic bone lesions confirmed by plain films
  • •5\. Life expectancy of at least 10 months
  • •6\. Performance status (Eastern Cooperative Oncology Group \[ECOG]) of 1\-2
  • •7\. Satisfactory haematological and blood chemistry values
  • •8\. No previous continuous treatment (\> four doses) with a bisphosphate, or treatment with a bisphosphate within 3 months of the start of treatment. Treatment with another bisphosphate is not allowed at any time during the trial.
  • •9\. Patients for whom orthopaedic surgery to bone or radiation therapy to bone is currently scheduled to treat skeletal disease related to metastatic bone lesions may not enter the trial. A previous history of such procedures is permitted only if the procedure was completed more than 2 weeks prior to the start of treatment
  • •10\. Patients who develop hypercalcaemia may be treated with a standard therapy other than a bisphosphate and remain on the trial

Exclusion Criteria

  • •Not provided at time of registration

Outcomes

Primary Outcomes

Not specified

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