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

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00912938
• Other study ID #: KBCSG001
• Status: Active, not recruiting
• Phase: Phase 4
• First received: June 2, 2009
• Last updated: February 14, 2010
• Start date: December 2007
• Est. completion date: December 2010

Study information

• Verified date: February 2010
• Source: Korean Breast Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 237
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Surgery, Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korean Breast Cancer Study Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary NTX and serum osteocalcin will be assessed at baseline, 3, 6, 9, and 12 months and when unexpected skeletal related events is detected.		one year	Yes