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

February 14, 2010 updated by: Korean Breast Cancer Study Group

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

237

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Department of Surgery, Korea University Guro Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zoledronic acid
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.
Drug: zoledronic acid
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.
Other Names:
  • ZOMETA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korean Breast Cancer Study Group

Investigators

  • Principal Investigator: Jae Bok Lee, MD.PhD, Department of Surgery, Korea University Guro Hospital, South Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

June 2, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (Estimate)

June 3, 2009

Study Record Updates

Last Update Posted (Estimate)

February 17, 2010

Last Update Submitted That Met QC Criteria

February 14, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KBCSG001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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