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

Korean Breast Cancer Study Group

Status and phase: Unknown; Phase 4

Conditions: Metastatic Breast Cancer

Treatments: Drug: zoledronic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT00912938

KBCSG001

Details and patient eligibility

About

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.

Full 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

Enrollment: 237 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

237 participants in 1 patient group

Zoledronic acid

Experimental group

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.

Treatment:

Drug: zoledronic acid