Bone Response in Metastatic Breast Cancer Involving Bones

NCT00420433 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 37

Last updated 2016-02-19

No results posted yet for this study

Summary

Primary Objectives:

* To estimate and compare the sensitivity and specificity of computed tomography (CT), plain radiography (XR), and skeletal scintigraphy (SS) with each other for the assessment of response of bone metastasis in patients with breast cancer.
* To estimate and compare the sensitivity and specificity of M. D. Anderson (MDACC) bone metastasis criteria with that of current criteria (UICC, WHO) in breast cancer patients for the assessment of the behavior of osseous metastasis in breast cancer patients.

Secondary Objective:

* To evaluate the progression free survival (PFS) and overall survival (OS) of each response group (CR, PR, SD, PD) assessed by imaging and response criteria.

Conditions

Interventions

PROCEDURE

Skeletal Scintigraphy

Performed before treatment and again at 3, 6, 9, and 12 months after starting anticancer therapy.

PROCEDURE

Radiography

Performed before treatment and again at 3, 6, 9, and 12 months after starting anticancer therapy.

PROCEDURE

CT Scan

CT scan will include your chest, abdomen, and pelvis. Performed before treatment and again at 3, 6, 9, and 12 months after starting anticancer therapy.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Naoto Ueno, MD, PhD · M.D. Anderson Cancer Center

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2008-10-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00420433 on ClinicalTrials.gov