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

Tracking Information

First Received Date ^ICMJE

December 9, 2005

Last Updated Date

June 1, 2007

Start Date ^ICMJE

September 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00264082 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Screening, Longitudinal, Defined Population, Retrospective/Prospective Study

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: Zometa(drug)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

-

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00264082

Responsible Party

Study ID Numbers ^ICMJE

419.04

Study Sponsor ^ICMJE

James Graham Brown Cancer Center

Collaborators ^ICMJE

University of Louisville

Investigators ^ICMJE

Principal Investigator:

Leela Bhupalam, MD

University of Louisville, James Graham Brown Cancer Center

Information Provided By

James Graham Brown Cancer Center

Verification Date

June 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP