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

This study has been completed.
Sponsor:
Collaborator:
University of Louisville
Information provided by (Responsible Party):
James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:
NCT00264082
First received: December 9, 2005
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Zometa(drug)
Phase 2

Study Type: Observational
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"

Resource links provided by NLM:


Further study details as provided by James Graham Brown Cancer Center:

Estimated Enrollment: 30
Study Start Date: September 2004
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264082

Locations
United States, Kentucky
James Graham Brown Cancer Center, 529 S. Jackson St.
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
James Graham Brown Cancer Center
University of Louisville
Investigators
Principal Investigator: Leela Bhupalam, MD University of Louisville, James Graham Brown Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT00264082     History of Changes
Other Study ID Numbers: 419.04
Study First Received: December 9, 2005
Last Updated: April 8, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Bone Resorption
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 16, 2014