Bone Response in Metastatic Breast Cancer Involving Bones

February 17, 2016 updated by: M.D. Anderson Cancer Center

Prospective Study of Tumor Response Assessment in Metastatic Breast Cancer Involving Bones

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will compare plain x-rays (XR), skeletal scintigraphy (SS), computed tomography (CT), magnetic resonance imaging (MRI), and positron emission tomography/CT (PET/CT) in measuring response. MRI and PET/CT can be performed if they are needed by standard of care. We anticipate MRI will be performed most commonly due to back pain.

Researchers will also compare three sets of standardized evaluation criteria (UICC criteria, WHO criteria, MDACC criteria). The MDACC criteria are new while the UICC and the WHO are standard criteria. The old criteria are no longer thought to be as reliable because they are based only on older technology (XR and SS). Since newer technologies are not included in the old criteria, most cancer doctors do not use these older criteria for evaluation of bone lesions. Therefore, new bone tumor criteria including newer imaging techniques (CT and MRI) are needed. At the end of the study, researchers will look at how sensitive and clear each imaging technique is, and they will use a set of criteria to learn which technique best measures the disease's response to therapy.

Participants in this study will have a complete physical exam, including a score of their bone pain. Routine blood tests (between 1-2 tablespoons) will be performed before participation in this study begins. Women who are able to have children must have a negative blood pregnancy test before starting treatment.

Participants will also have imaging examinations (XR, SS, CT, and MRI, PET/CT).

All of the first examinations will be finished within one month before the start the anti-cancer therapy. If imaging examinations alone cannot prove that the disease has spread to the bone, a needle bone biopsy will be done. A bone biopsy means that researchers will collect a couple of small tumor samples from the suspicious bone site. The tumor samples will be taken using a large needle while you are under the appropriate anesthesia.

If you are found to be eligible for this study, you will have imaging exams (described below), bone score evaluations, and blood tests (between 1-2 tablespoons) done before treatment and again at 3, 6, 9, and 12 months after starting anticancer therapy.

Plain radiographs:

Also called X-rays. You will receive a complete bone survey. This consists of 2 views of spine, one view of the top of your head, one view of your chest, one view of your pelvic bones, and two of your ribs, one from each side. Any other symptomatic bone scans will also be included.

Skeletal scintigraphy:

Also called bone scan. You should not eat for more than 4 hours before this examination. You will get the pictures 2-3 hour after intravenous injection of Technetium-99m bound to methylene diphosphonate (Tc-99m MDP).

CT:

CT scan will include your chest, abdomen, and pelvis. You should not eat for more than 6 hours before this examination. You will be given oral and intravenous contrast as is done in standard care.

MRI:

This is an optional procedure. MRI of the symptomatic areas will be performed and followed on the same schedule as other imaging. You will be given contrast dye by vein as is done in standard care.

PET/CT:

This is an optional procedure. The examination usually takes 30-40 min while you are lying on the moving bed with tunnel 60-90min after injection of 2-deoxy-2-[18F] fluoro-D-glucose (FDG) by vein. You should not eat for more than 6 hours before this examination.

Your part in the study will end after the 12 month tests. However, you will be monitored for 3 years after enrolling on this study.

This is an investigational study. This study is not focusing to test the treatment agents but to test the imaging technique assessing bone tumor response. The exams performed in this study are commercially available and are part of routine examination. A total of up to 120 patients will take part in the study. All will be enrolled at M. D. Anderson.

Study Type

Observational

Enrollment (Actual)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study participants with breast cancer that has spread to the bones.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • 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 Names:
  • Computed Tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare different imaging techniques in measuring the response of bone disease to treatment.
Time Frame: 5 Years
5 Years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

January 9, 2007

First Submitted That Met QC Criteria

January 10, 2007

First Posted (Estimate)

January 11, 2007

Study Record Updates

Last Update Posted (Estimate)

February 19, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003-0999

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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