Breast Cancer Clinical Trial
Official title:
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
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.
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.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
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