NCT00060138

Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases

A Phase I-II, 24-Week, Multi-Center, Double-Blind, Randomized, Dose-Ranging Study To Evaluate The Safety And Efficacy Of A Humanized Monoclonal Antibody To PTHrP Versus Zoledronic Acid In Patients With Breast Cancer Metastatic To Bone

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Chugai Pharmaceutical · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone. It is not yet known whether monoclonal antibody is more effective than zoledronate in treating women who have breast cancer and bone metastases. PURPOSE: Randomized phase I/II trial to compare the effectiveness of monoclonal antibody with that of zoledronate in treating women who have breast cancer and bone metastases.

Detailed description

OBJECTIVES: * Compare the safety and tolerability of monoclonal antibody CAL vs zoledronate in women with breast cancer and bone metastases. * Compare, preliminarily, the potential effects of these drugs on skeletal events/manifestations related to bone metastases, including hypercalcemia, bone pain, bone metastatic lesions, complications (e.g., pathologic fracture and spinal cord compression), and interventions (e.g., surgery and radiotherapy) in these patients. * Compare changes in ECOG performance status in patients treated with these drugs. * Determine the pharmacokinetics of monoclonal antibody CAL in these patients. OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to average prestudy pain score on question 3 of a daily electronic telephone pain diary (less than 3 vs 3 or more) and prior bisphosphonate therapy (yes vs no). Patients are randomized to 1 of 4 treatment arms. * Arm I: Patients receive monoclonal antibody CAL IV over 30-60 minutes on day 1. * Arm II: Patients receive a lower dose of monoclonal antibody CAL as in arm I. * Arm III: Patients receive a lower dose (lower than arm II) of monoclonal antibody CAL as in arm I. * Arm IV: Patients receive zoledronate IV over 30-60 minutes on day 1. Treatment in all arms repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients keep a pain diary throughout study participation. Patients are followed at 24 weeks. PROJECTED ACCRUAL: A total of 72 patients (18 per treatment arm) will be accrued for this study.

Conditions

• Breast Cancer
• Hypercalcemia of Malignancy
• Metastatic Cancer
• Pain

Interventions

Type	Name	Description
BIOLOGICAL	monoclonal antibody CAL
DRUG	zoledronic acid

Timeline

• Start date: 2002-11-01
• Primary completion: 2004-09-01
• First posted: 2003-05-07
• Last updated: 2013-05-15

Locations

1 site across 1 country: United States