Bone Response in Metastatic Breast Cancer Involving Bones
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
|
Show Detailed Description 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:
- 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)
- Zubrod performance status 2 or less. (APPENDIX A)
- Patient must receive systemic treatment (e.g., chemotherapy, hormonal therapy) for this newly diagnosed metastatic disease. (Additional bisphosphonate treatment will be acceptable.)
- 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:
- Patients who have less than 3 months interval from completion of treatment (chemotherapy and/or radiation therapy) for primary breast cancer.
- Patients who have the history of radiation therapy for bone disease.
- History or presence of brain/leptomeningeal metastasis.
- 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 May 16, 2013