Clinical trial · Observational
Bone Response in Metastatic Breast Cancer Involving Bones
Prospective Study of Tumor Response Assessment in Metastatic Breast Cancer Involving Bones
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastases | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT Scan | Procedure | — | UNRESOLVED |
| Radiography | Procedure | — | UNRESOLVED |
| Skeletal Scintigraphy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- Patients with breast cancer that has spread to the bones.
- interventionNames
- Procedure: Skeletal Scintigraphy
- Procedure: Radiography
- Procedure: CT Scan
Primary outcomes (1)
- measure
- To compare different imaging techniques in measuring the response of bone disease to treatment.
- timeFrame
- 5 Years
Secondary outcomes (2)
- measure
- To compare different evaluation techniques (evaluation criteria) in reading the images.
- timeFrame
- 5 Years
- measure
- To study the change in the response of blood serum markers and the reliability of biochemical markers.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available