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

Sponsor
University of Louisville (Other)
Overall Status
Completed
CT.gov ID
NCT00264082
Collaborator
James Graham Brown Cancer Center (Other)
30
Enrollment
1
Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Time Perspective:
Other
Official Title:
"Tartrate-Resistant Acid Phosphatase as a Bone Resorption Marker in Stage IV Breast Cancer Patients With Bone Metastasis During Zometa Treatment: A Pilot Study"
Study Start Date :
Sep 1, 2004
Actual Primary Completion Date :
May 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 James Graham Brown Cancer Center, 529 S. Jackson St. Louisville Kentucky United States 40202

    Sponsors and Collaborators

    • University of Louisville
    • James Graham Brown Cancer Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    University of Louisville
    ClinicalTrials.gov Identifier:
    NCT00264082
    Other Study ID Numbers:
    • 419.04
    First Posted:
    Dec 12, 2005
    Last Update Posted:
    Dec 29, 2017
    Last Verified:
    Dec 1, 2017
    Additional relevant MeSH terms:
    Breast Neoplasms
    Bone Resorption
    Zoledronic Acid

    Study Results

    No Results Posted as of Dec 29, 2017