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

NCT00060138 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2013-05-15

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

monoclonal antibody CAL

DRUG

zoledronic acid

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Chugai Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Paula Silverman, MD · Case Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Primary Completion
2004-09-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00060138 on ClinicalTrials.gov