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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. Identifier: NCT00051779
Recruitment Status : Completed
First Posted : January 17, 2003
Last Update Posted : June 24, 2005
Information provided by:
Chugai Pharma USA

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Breast Cancer Metastasis Drug: CAL Phase 1

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Major Inclusion Criteria - Others Stipulated within the Protocol

The study physician must assure you have/are:

  • Must be a female at least 18 years of age and be using an effective form of birth control.
  • A documented history of breast cancer and at least one bone metastasis that has not been previously treated by radiation or surgery, and is not anticipated to be treated within the next 24 weeks.
  • A total body bone scan and other radiographic scan(s) performed on you within 4 weeks prior to or during the screening period sufficient to image all sites of bone metastases.
  • You must be willing to perform a daily telephone diary and be willing to keep a paper diary and provide voluntary consent to participate in this study.

Major Exclusion Criteria - Others Stipulated within the Protocol

The study physician must assure you do not have/are not:

  • A change in analgesic (pain relief) type medication during the screening period (example, non-narcotic to narcotic).
  • Received radiation therapy to any bone metastasis or started a new course of chemotherapy within 3 weeks prior to the screening visit or during the screening period.
  • Used any bisphosphonate type drug during the 30 days prior to the anticipated first dose of study drug
  • Vertebral spine or weight-bearing bone metastasis that would place you at imminent risk for fracture or surgical intervention.
  • Evidence of active infection or immune deficiency, renal failure, abnormal liver function, or a serum calcium level > 10.1 mg/dL.
  • Use of any investigational drug within 30 days prior to screening.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00051779

Show Show 38 study locations
Sponsors and Collaborators
Chugai Pharma USA
Layout table for additonal information Identifier: NCT00051779    
Other Study ID Numbers: CAL-03
First Posted: January 17, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: February 2004
Keywords provided by Chugai Pharma USA:
Parathyroid hormone-related protein (PTHrP)
Breast Cancer
Bone Metastasis
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes