Clinical Trial: Comparison of Two Schedules of Zoledronic Acid in Treating Patients With Breast Cancer That Has Spread to the Bone

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Cost-Effective Use of Bisphosphonates in Metastatic Bone Disease - A Comparison of Bone Marker Directed Zoledronic Acid Therapy to a Standard Schedule

Brief Summary:

RATIONALE: Zoledronic acid may help decrease the risk of broken bones, bone pain, and other symptoms caused by bone metastases. It may also help patients live more comfortably.

PURPOSE: This randomized clinical trial is studying different schedules of zoledronic acid to compare how well they work in treating patients with breast cancer that has spread to the bone.


Detailed Summary:

OBJECTIVES:

Primary

  • Compare the frequency and timing of serious related events (e.g., fractures, radiotherapy to bone, hypercalcemia of malignancy, orthopedic surgery, and spinal cord compression) in patients with advanced breast cancer metastatic to the bone treated with bone marker-directed schedule vs standard schedule zoledronic acid.

Secondary

  • Compare the quality of life of patients treated with these regimens.
  • Compare the clinical burden of skeletal complications in these patients.
  • Compare pain, performance status, and analgesic use (PPA score) in these patients.
  • Compare the incidence of new bone metastases in these patients.
  • Compare overall survival of these patients.
  • Compare bisphosphonate use and expenditure on administration in these patients.

OUTLINE: This is an open-label, randomized, controlled, parallel-group, multicenter study. Patients are stratified according to treatment center, gender, type of concurrent systemic therapy at study entry (endocrine therapy [with or without trastuzumab (Herceptin^®)] vs chemotherapy [with or without trastuzumab] vs trastuzumab alone vs chemotherapy and endocrine therapy [with or without trastuzumab] vs no systemic anticancer treatment), prior skeletal-related event (yes vs no), duration of bisphosphonate use for metastatic disease prior to study entry (4-6 months vs 6-12 months), type of metastases present at study entry (bone only vs bone and soft tissue vs bone and viscer
Sponsor: University of Leeds

Current Primary Outcome:

  • Fractures
  • Radiotherapy to bone either for relief of pain or to treat or prevent pathological fractures or spinal cord compression
  • Hypercalcemia of malignancy
  • Orthopedic surgery to prevent or treat pathological fractures or spinal cord compression
  • Spinal cord compression


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of life as measured by QLQ-C30 and the QLQ-BR23 breast-specific module
  • Clinical burden of skeletal complications
  • Pain, performance status, and analgesic use
  • Incidence of new bone metastases
  • Overall survival
  • Bisphosphonate use and expenditure on administration
  • Health care utilization
  • Clinical utility of the "point of care" test for N-telopeptides (NTx) excretion


Original Secondary Outcome: Same as current

Information By: National Cancer Institute (NCI)

Dates:
Date Received: April 9, 2007
Date Started: March 2006
Date Completion:
Last Updated: August 23, 2013
Last Verified: November 2007