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

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: NCT00060138
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : May 15, 2013
National Cancer Institute (NCI)
Information provided by:
Chugai Pharmaceutical

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Hypercalcemia of Malignancy Metastatic Cancer Pain Biological: monoclonal antibody CAL Drug: zoledronic acid Phase 1 Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Supportive Care
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
Study Start Date : November 2002
Actual Primary Completion Date : September 2004

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


  • Histologically or cytologically confirmed breast cancer
  • Radiographical evidence of at least 1 bone metastasis

    • No prior radiotherapy or surgery to bone metastasis
    • No radiotherapy or surgery anticipated for bone metastasis within the next 24 weeks
  • Bone pain severity score of at least 1 on 5 of 7 days as determined by question 3 of the Brief Pain Inventory (BPI)
  • No bone metastases to a weight-bearing bone at imminent risk for pathologic fracture or surgical intervention
  • No vertebral metastases that place the patient at imminent risk of spinal cord compression
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Female

Menopausal status

  • Pre- or post-menopausal

Performance status

  • ECOG 0-2

Life expectancy

  • At least 6 months


  • WBC at least 2,000/mm^3
  • Lymphocyte count at least 500/mm^3
  • Granulocyte count at least 1,000/mm^3
  • Platelet count at least 50,000/mm^3


  • ALT or AST no greater than 2.5 times upper limit of normal (ULN)
  • Bilirubin no greater than 1.5 times ULN


  • Calcium no greater than 10.1 mg/dL
  • No oliguria, defined as less than 30 mL urine per 2-hour collection
  • No acute renal failure
  • Creatinine no greater than 2.5 mg/dL


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception
  • No sepsis
  • No known or anticipated contraindication to study drugs


Biologic therapy

  • Not specified


  • More than 3 weeks since initiation of a new chemotherapy regimen

Endocrine therapy

  • More than 3 weeks since initiation of a new hormonal therapy regimen


  • See Disease Characteristics
  • More than 3 weeks since prior radiotherapy


  • See Disease Characteristics


  • More than 60 days since prior bisphosphonates
  • More than 30 days since prior investigational drugs
  • No change in analgesic drug regimen during the screening period

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): NCT00060138

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United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Chugai Pharmaceutical
National Cancer Institute (NCI)
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Study Chair: Paula Silverman, MD Case Comprehensive Cancer Center
Layout table for additonal information Identifier: NCT00060138    
Other Study ID Numbers: CWRU-080235
CDR0000299530 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: May 7, 2003    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: May 2013
Keywords provided by Chugai Pharmaceutical:
hypercalcemia of malignancy
stage IV breast cancer
recurrent breast cancer
bone metastases
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Zoledronic Acid
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Bone Density Conservation Agents