Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT00420433
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00420433
Study Brief:
Protocol Section:
NCT00420433