NCT00264082

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Last Updated

December 29, 2017

Status Verified

December 1, 2017

Enrollment Period

1.7 years

First QC Date

December 9, 2005

Last Update Submit

December 27, 2017

Conditions

Breast Cancer

Interventions

Zometa(drug)DRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James Graham Brown Cancer Center, 529 S. Jackson St.

Louisville, Kentucky, 40202, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Leela Bhupalam, MD

    University of Louisville, James Graham Brown Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2005

First Posted

December 12, 2005

Study Start

September 1, 2004

Primary Completion

May 1, 2006

Last Updated

December 29, 2017

Record last verified: 2017-12

Locations

US(1)