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 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT01784393
Eligibility Criteria:
Inclusion Criteria:
1. The patient must be 18 years of age or older
2. The patient must have histologically proven breast adenocarcinoma
3. Radiographic evidence of bone metastasis is required .Acceptable studies include plain radiographs, radionuclide bone scans, computed tomography scans and magnetic resonance imaging
4. The patient must have pain that appears to be related to the radiographically documented metastasis
5. Patients receiving systemic therapy with Capecitabine to metastatic disease (according to health basket)
6. Patients must have an estimated life expectancy of 3 months or greater
7. Patients will be eligible for treatment of multiple metastases only if these can be included in no more than two treatment sites
8. Signed study specific informed consent
9. Karnofsky Performance Status \> 40
10. Calculated Creatinine Clearance \> 50 ml/min
11. ALT and AST no greater than 3 5 times the institutional normal; bilirubin and serum creatinine no greater than 1.5 times normal; ANC greater than 1500, and platelets at least 100,00
Exclusion Criteria:
1. Prior radiation therapy or prior palliative surgery to the painful site
2. Impending fracture of the treatment site or planned surgical fixation of the bone
3. Patients with clinical or radiographic evidence of spinal cord or cauda equina compression
4. Patients receiving systemic radionuclides (strontium, samarium, etc.) within 60 days prior to registration
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01784393
Study Brief:
Protocol Section:
NCT01784393