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Bone Response in Metastatic Breast Cancer Involving Bones

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00420433
First Posted: January 11, 2007
Last Update Posted: February 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose

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.

Condition Intervention
Breast Cancer Bone Metastases Procedure: Skeletal Scintigraphy Procedure: Radiography Procedure: CT Scan

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Study of Tumor Response Assessment in Metastatic Breast Cancer Involving Bones

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To compare different imaging techniques in measuring the response of bone disease to treatment. [ Time Frame: 5 Years ]

Secondary Outcome Measures:
  • To compare different evaluation techniques (evaluation criteria) in reading the images. [ Time Frame: 5 Years ]
  • To study the change in the response of blood serum markers and the reliability of biochemical markers. [ Time Frame: 5 Years ]

Enrollment: 37
Study Start Date: September 2004
Study Completion Date: May 2012
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients with breast cancer that has spread to the bones.
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.
Other Name: X-Ray
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.
Other Name: Computed Tomography

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study participants with breast cancer that has spread to the bones.
Criteria

Inclusion Criteria:

  1. Newly diagnosed bone (from calvarium to pelvis include ribs and sternum) and nonosseous (it should be measurable by CT) metastasis or primary breast tumor (with a confirmation of no surgical treatment for 12 months) from breast cancer. If the bone metastasis is not confirmed by imaging, bone biopsy is needed. Please see diagnostic flow sheet. (APPENDIX B)
  2. Zubrod performance status 2 or less. (APPENDIX A)
  3. Patient must receive systemic treatment (e.g., chemotherapy, hormonal therapy) for this newly diagnosed metastatic disease. (Additional bisphosphonate treatment will be acceptable.)
  4. Patients must sign an informed consent document indicating awareness that this study is not focusing on the verification of treatment agents but on verification of modalities to assess bone tumor response, in keeping with institutional policy.

Exclusion Criteria:

  1. Patients who have less than 3 months interval from completion of treatment (chemotherapy and/or radiation therapy) for primary breast cancer.
  2. Patients who have the history of radiation therapy for bone disease.
  3. History or presence of brain/leptomeningeal metastasis.
  4. History of other malignancies except cured non-melanoma skin cancer or cured cervical carcinoma in situ
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00420433


Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Naoto Ueno, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00420433     History of Changes
Other Study ID Numbers: 2003-0999
First Submitted: January 9, 2007
First Posted: January 11, 2007
Last Update Posted: February 19, 2016
Last Verified: May 2012

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Bone Metastases
Radiography
X-Ray
Computed Tomography
CT Scan
Skeletal Scintigraphy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes