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

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Breast Cancer, Bone Metastases

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Trial Information

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

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 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.


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.


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.

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

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

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

To compare different imaging techniques in measuring the response of bone disease to treatment.

Outcome Time Frame:

5 Years

Safety Issue:


Principal Investigator

Naoto Ueno, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

September 2004

Completion Date:

Related Keywords:

  • Breast Cancer
  • Bone Metastases
  • Breast Cancer
  • Bone Metastases
  • Radiography
  • X-Ray
  • Computed Tomography
  • CT Scan
  • Skeletal Scintigraphy
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Bone Neoplasms
  • Bone Marrow Diseases



UT MD Anderson Cancer Center Houston, Texas  77030