Assessment of Tartrate-Resistant Acid Phosphatase (TRAP) as a Bone Resorption Marker in Stage IV Breast Cancer Patients With Bone Metastasis

December 27, 2017 updated by: University of Louisville

"Tartrate-Resistant Acid Phosphatase as a Bone Resorption Marker in Stage IV Breast Cancer Patients With Bone Metastasis During Zometa Treatment: A Pilot Study"

The purpose of this research study is to evaluate the usefulness of the TRAP protein as (1) an early indicator of bone destruction and (2) a tool for assessing the effect of Zometa® in treating symptoms of bone metastases due to breast cancer. Tartrate-resistant acid phosphatase (TRAP) is a protein released into the blood stream as a result of bone destruction caused by metastasis of breast cancer to the bone. Bone destruction causes pain and bone fractures. This study will measure TRAP levels in serum taken from breast cancer patients to see if TRAP levels will be able to predict the effect of Zometa® treatment on bone destruction, pain and bone fractures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • James Graham Brown Cancer Center, 529 S. Jackson St.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Histologic or cytologic documentation of breast cancer.
  2. Stage IV Breast Cancer Patients with bone metastasis for whom Zometa treatment will be initiated.
  3. Age > 18
  4. Written informed consent prior to study entry
  5. Patients may be currently receiving hormone therapy, chemotherapy and/or radiation therapy to the primary tumor.
  6. Life expectancy of at least 6 months.
  7. We will include patients who have had previous or current radiation therapy to breast

Exclusion Criteria:

  1. Concurrent malignancy with a second primary
  2. Stage I, Stage II and Stage III
  3. ECOG Performance Status 3 or 4.
  4. Renal Failure - serum creatinine >2.O mg/dL at screening
  5. AST or ALT > ULN X 3. at screening
  6. Bilirubin > 3.0 mg/dL at screening
  7. Pregnant women
  8. Prior or current bisphosphonate therapy
  9. Any skeletal related event due to malignancy prior to study enrollment.
  10. Patients with osteoporotic fractures prior to study enrollment.
  11. Allergy to bisphosphonates
  12. Any radiation therapy for the treatment of bone metastases <4 weeks prior to study start.
  13. Any chronic medical condition which would preclude performance or adherence to protocol requirements

  14. Inability to provide informed consent

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Other

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

James Graham Brown Cancer Center

Investigators

  • Principal Investigator: Leela Bhupalam, MD, University of Louisville, James Graham Brown Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

December 9, 2005

First Submitted That Met QC Criteria

December 9, 2005

First Posted (Estimate)

December 12, 2005

Study Record Updates

Last Update Posted (Actual)

December 29, 2017

Last Update Submitted That Met QC Criteria

December 27, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 419.04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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