An Investigational Drug (CAL) Versus Zoledronic Acid (Zometa®) in Patients With Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00051779|
Recruitment Status : Completed
First Posted : January 17, 2003
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms Breast Cancer Metastasis||Drug: CAL||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A 24-Week Blinded Study Conducted at Multiple Centers, Evaluating the Safety and Effectiveness of Various Doses of the Investigational Drug (CAL) Versus Zoledronic Acid (Zometa®) When Randomly Assigned to Patients With Breast Cancer That Has Metastasized to Bone|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051779