An Investigational Drug (CAL) Versus Zoledronic Acid (Zometa®) in Patients With Breast Cancer
NCT00051779 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2005-06-24
Summary
This study is intended to evaluate the safety, tolerability, and possible effectiveness of an investigational humanized monoclonal antibody (CAL) to the parathyroid hormone-related protein (PTHrP) when compared to zoledronic acid in patients with breast cancer metastatic to bone.
The study will also evaluate the possible effects of both study drugs on performance status, markers of bone metabolism, and skeletal events related to bone metastasis including elevated blood calcium levels, bone pain, metastatic lesions, complications and interventions. The levels of CAL in the blood will also be evaluated.
Conditions
- Breast Neoplasms
- Breast Cancer
- Metastasis
Interventions
- DRUG
-
CAL
Sponsors & Collaborators
-
Chugai Pharma USA
lead INDUSTRY
Study Design
- Purpose
- TREATMENT
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United States
Study Locations
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