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Evaluate the Relationship of Bone Remodeling Markers for Skeletal Complications in Metastatic Breast Cancer Patients

Primary Purpose

Metastatic Breast Cancer

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
zoledronic acid
Sponsored by
Korean Breast Cancer Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Metastatic Breast Cancer focused on measuring metastatic breast cancer, bone remodeling markers, zoledronic acid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with advanced breast cancer with radiographic confirmation of bone metastases (minimum of one bone scan lesion must be confirmed as metastatic on plain radiographs or CT/MR imaging)
  2. Men or women aged ≥ 18 years
  3. WHO (ECOG) performance status 0-2
  4. Women of child-bearing potential must be using a reliable and appropriate method of contraception
  5. Urine sample taken and sent to the central laboratory for baseline Ntx analysis
  6. Written informed consent.

Exclusion Criteria:

  1. Bisphosphonate treatment within the 4 weeks prior to planned first study treatment
  2. Abnormal renal function as evidenced by a calculated creatinine clearance < 30 ml/minute
  3. Poor venous access
  4. Metabolic bone disease
  5. Unable to comply with study procedures, especially the reliable collection of urine samples for bone resorption marker measurements
  6. Estimated life expectancy of < 6 months
  7. Treatment with systemic bone seeking radioisotopes within the 3 months prior to study entry
  8. Wide field (hemi-body) radiotherapy within the 3 months prior to study entry
  9. Concomitant medication with drugs known to affect bone metabolism
  10. Pregnancy or breast-feeding
  11. Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular), or a current or prior diagnosis of osteonecrosis of the jaw (ONJ)
  12. Recent (within 4 weeks of study entry*) or planned dental or jaw surgery

Sites / Locations

  • Department of Surgery, Korea University Guro Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zoledronic acid

Arm Description

Patients with advanced breast cancer with radiographic confirmation of bone metastases. This arm will be receiving zoledronic acid administration. The primary endpoint is to find the correlation between bone turnover markers and the frequency of skeletal-related-events for one year. Skeletal related events are defined as pathologic fractures, the need for radiation therapy, orthopaedic surgery, hypercalcemia of malignancy and spinal cord compression. A total of 237 patients will be included.

Outcomes

Primary Outcome Measures

Urinary NTX and serum osteocalcin will be assessed at baseline, 3, 6, 9, and 12 months and when unexpected skeletal related events is detected.

Secondary Outcome Measures

Full Information

First Posted
June 2, 2009
Last Updated
February 14, 2010
Sponsor
Korean Breast Cancer Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT00912938
Brief Title
Evaluate the Relationship of Bone Remodeling Markers for Skeletal Complications in Metastatic Breast Cancer Patients
Official Title
A Phase IV, Multi-center, Open Label, Single Arm Clinical Trial to Evaluate the Relationship of Bone Remodeling Markers for Skeletal Complications in Metastatic Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Korean Breast Cancer Study Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
to evaluate whether bone marker can provide the valuable predictor of skeletal complications and whether regular assessing of NTX(N-telopeptide of type I collagen) and osteocalcin can be useful in advanced breast cancer patients with bone metastasis receiving zoledronic acid.
Detailed Description
to evaluate the efficacy and safety of zoledronic acid by measuring changes in bone turnover markers the incidence of skeletal-related events time to skeletal-related events time to bone metastases progression overall survival the incidence of each adverse event including osteonecrosis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
metastatic breast cancer, bone remodeling markers, zoledronic acid

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
237 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zoledronic acid
Arm Type
Experimental
Arm Description
Patients with advanced breast cancer with radiographic confirmation of bone metastases. This arm will be receiving zoledronic acid administration. The primary endpoint is to find the correlation between bone turnover markers and the frequency of skeletal-related-events for one year. Skeletal related events are defined as pathologic fractures, the need for radiation therapy, orthopaedic surgery, hypercalcemia of malignancy and spinal cord compression. A total of 237 patients will be included.
Intervention Type
Drug
Intervention Name(s)
zoledronic acid
Other Intervention Name(s)
ZOMETA
Intervention Description
Intravenous zoledronic acid 4mg over a minimum of 15 minutes in at least 100mls of calcium free infusion solution (0.9% sodium chloride or 5% glucose solution) every 4 weeks.
Primary Outcome Measure Information:
Title
Urinary NTX and serum osteocalcin will be assessed at baseline, 3, 6, 9, and 12 months and when unexpected skeletal related events is detected.
Time Frame
one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with advanced breast cancer with radiographic confirmation of bone metastases (minimum of one bone scan lesion must be confirmed as metastatic on plain radiographs or CT/MR imaging) Men or women aged ≥ 18 years WHO (ECOG) performance status 0-2 Women of child-bearing potential must be using a reliable and appropriate method of contraception Urine sample taken and sent to the central laboratory for baseline Ntx analysis Written informed consent. Exclusion Criteria: Bisphosphonate treatment within the 4 weeks prior to planned first study treatment Abnormal renal function as evidenced by a calculated creatinine clearance < 30 ml/minute Poor venous access Metabolic bone disease Unable to comply with study procedures, especially the reliable collection of urine samples for bone resorption marker measurements Estimated life expectancy of < 6 months Treatment with systemic bone seeking radioisotopes within the 3 months prior to study entry Wide field (hemi-body) radiotherapy within the 3 months prior to study entry Concomitant medication with drugs known to affect bone metabolism Pregnancy or breast-feeding Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular), or a current or prior diagnosis of osteonecrosis of the jaw (ONJ) Recent (within 4 weeks of study entry*) or planned dental or jaw surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Bok Lee, MD.PhD
Organizational Affiliation
Department of Surgery, Korea University Guro Hospital, South Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Evaluate the Relationship of Bone Remodeling Markers for Skeletal Complications in Metastatic Breast Cancer Patients

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