Comparison of Two Schedules of Zoledronic Acid in Treating Patients With Breast Cancer That Has Spread to the Bone
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00458796|
Recruitment Status : Unknown
Verified November 2007 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : April 11, 2007
Last Update Posted : August 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Hypercalcemia of Malignancy Metastatic Cancer Musculoskeletal Complications Pain||Drug: zoledronic acid Procedure: quality-of-life assessment||Not Applicable|
- 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.
- 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 visceral metastases vs bone, soft tissue, and visceral metastases). Patients are randomized to 1 of 2 treatment arms.
- Arm I (standard schedule): Patients receive zoledronic acid IV over 15 minutes once every 3-4 weeks for 24 months.
- Arm II (bone marker-directed schedule): Patients receive zoledronic acid IV over 15 minutes once every 3-4, 8-9, or 15-16 weeks (based on serum N-telopeptide:creatinine ratio) for 24 months.
Quality of life is assessed at baseline and at 3, 6, 9, 12, 18, and 24 months.
After completion of study therapy, patients are followed periodically for up to 3 years.
PROJECTED ACCRUAL: A total of 1,500 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1500 participants|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Cost-Effective Use of Bisphosphonates in Metastatic Bone Disease - A Comparison of Bone Marker Directed Zoledronic Acid Therapy to a Standard Schedule|
|Study Start Date :||March 2006|
- 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
- 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
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): NCT00458796
|Royal Bournemouth Hospital||Recruiting|
|Bournemouth, England, United Kingdom, BH7 7DW|
|Contact: Tamas Hickish, MD 44-1202-704-789 firstname.lastname@example.org|
|Derbyshire Royal Infirmary||Recruiting|
|Derby, England, United Kingdom, DE1 2QY|
|Contact: Pamela Woodings, MRCP, FRCR, MBCHB 44-1332-347-141 ext. 4575|
|Doncaster Royal Infirmary||Recruiting|
|Doncaster, England, United Kingdom, DN2 5LT|
|Contact: Doncaster Royal Infirmary 44-1302-366-666|
|University Hospital of North Durham||Recruiting|
|Durham, England, United Kingdom, DH1 5TW|
|Contact: Wendy Taylor, MD 44-19-333-2659|
|Diana Princess of Wales Hospital||Recruiting|
|Grimsby, England, United Kingdom, DN33 2BA|
|Contact: Sunil Upadhyay, MD 44-147-287-4111|
|St. Luke's Cancer Centre at Royal Surrey County Hospital||Recruiting|
|Guildford, England, United Kingdom, GU2 7XX|
|Contact: Stephen J. Houston, MD 44-1483-571-122 ext. 6744 email@example.com|
|Huddersfield Royal Infirmary||Recruiting|
|Huddersfield, West Yorks, England, United Kingdom, HD3 3EA|
|Contact: Johnathan Joffe, MD 44-1484-342-150 firstname.lastname@example.org|
|Royal Liverpool University Hospital||Recruiting|
|Liverpool, England, United Kingdom, L7 8XP|
|Contact: Susan M. O, MD 44-151-334-1155|
|Saint Bartholomew's Hospital||Recruiting|
|London, England, United Kingdom, EC1A 7BE|
|Contact: Christopher J. Gallagher, MD 44-20-7601-8521 email@example.com|
|Manchester, England, United Kingdom, M20 4BX|
|Contact: Andrew M. Wardley, MD 44-161-446-3746 firstname.lastname@example.org|
|Manchester, England, United Kingdom, M20 8LR|
|Contact: Andrew M. Wardley, MD 44-161-611-3186|
|Clatterbridge Centre for Oncology||Recruiting|
|Merseyside, England, United Kingdom, CH63 4JY|
|Contact: Susan M. O, MD 44-151-334-1155 email@example.com|
|George Eliot Hospital||Recruiting|
|Nuneaton, England, United Kingdom, CV10 7DJ|
|Contact: Lydia Fresco, MD 44-247-686-5512|
|Dorset Cancer Centre||Recruiting|
|Poole Dorset, England, United Kingdom, BH15 2JB|
|Contact: Susan Dean, MD 44-1202-442-491|
|Scunthorpe General Hospital||Recruiting|
|Scunthorpe, England, United Kingdom, DN15 7BH|
|Contact: Thiagarajan Sreenivasant 44-0172-428-2282 ext. 5144|
|Cancer Research Centre at Weston Park Hospital||Recruiting|
|Sheffield, England, United Kingdom, S1O 2SJ|
|Contact: Robert E. Coleman, MD, FRCP 44-114-226-5213 firstname.lastname@example.org|
|Royal Shrewsbury Hospital||Recruiting|
|Shrewsbury, England, United Kingdom, SY3 8XQ|
|Contact: Rajiv K. Agrawal, MD 01743-261334 email@example.com|
|Solihull, England, United Kingdom, B91 2JL|
|Contact: Andrew Stockdale, MD 44-24-7696-7151|
|Southampton General Hospital||Recruiting|
|Southampton, England, United Kingdom, SO16 6YD|
|Contact: Peter Simmonds 44-23-8079-3627|
|South Warwickshire Hospital||Recruiting|
|Warwick, Warwickshire, England, United Kingdom, CV34 5BJ|
|Contact: David Jones, MD 44-24-7696-7151|
|Southend University Hospital NHS Foundation Trust||Recruiting|
|Westcliff-On-Sea, England, United Kingdom, SS0 0RY|
|Contact: Anne Robinson, MD 44-1702-221-226|
|Royal Hampshire County Hospital||Recruiting|
|Winchester, England, United Kingdom, SO22 5DG|
|Contact: Virginia Hall, MD 44-1962-863-535|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Contact: Mohammed Rizwanullah, MD 44-0141-211-2860|
|Beatson West of Scotland Cancer Centre||Recruiting|
|Glasgow, Scotland, United Kingdom, G12 0YN|
|Contact: Jonathan Hicks, MD 44-169-836-6729 firstname.lastname@example.org|
|Glasgow, Scotland, United Kingdom, G12 0YN|
|Contact: Hosney M. A. Yosef, MD 44-141-301-7066|
|Kilmarnock, Scotland, United Kingdom, KA2 OBE|
|Contact: Diana Ritchie, MD 44-141-221-1724|
|Velindre Cancer Center at Velindre Hospital||Recruiting|
|Cardiff, Wales, United Kingdom, CF14 2TL|
|Contact: Peter J. Barrett Lee, MD 44-29-2031-6292|
|Withybush General Hospital||Recruiting|
|Haverfordwest, Wales, United Kingdom, SA61 2PZ|
|Contact: Gianfilippo Bertelli, MD, FRCPE 44-1437-764-545|
|Royal Gwent Hospital||Recruiting|
|Newport Gwent, Wales, United Kingdom, NP9 2UB|
|Contact: Christopher Gaffney, MD 44-163-323-4266|
|South West Wales Cancer Institute||Recruiting|
|Swansea, Wales, United Kingdom, SA2 8QA|
|Contact: Gianfilippo Bertelli, MD, FRCPE 44-179-228-5826 email@example.com|
|Study Chair:||Robert E. Coleman, MD, FRCP||Cancer Research Centre at Weston Park Hospital|