Bone Response in Metastatic Breast Cancer Involving Bones

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00420433
First received: January 9, 2007
Last updated: May 23, 2012
Last verified: May 2012
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare different evaluation techniques (evaluation criteria) in reading the images. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
  • To study the change in the response of blood serum markers and the reliability of biochemical markers. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: September 2004
Primary Completion Date: May 2012 (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

  Hide Detailed Description

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.

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00420433     History of Changes
Other Study ID Numbers: 2003-0999
Study First Received: January 9, 2007
Last Updated: May 23, 2012
Health Authority: United States: Institutional Review Board

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
Bone Neoplasms
Bone Marrow Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on April 23, 2014