None listed
Conditions
Interventions
Radiation : 223Ra dichloride, 55 kBq/kg body weight, will be administered as a bolus intravenous (IV) injection (up to 1 minute) on Day 1 of each cycle (three times at intervals of 4 weeks)
Sponsors
Korea Cancer Center Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Histopathologically confirmed breast cancer patients with positive estrogen receptors, HER2 negative (ER + / HER2-) 2. Breast cancer patients with confirmed bone metastases - who has radiologic evidence of at least two measurable bone metastases (radionuclide bone scan, CT scan or MRI) within 12 weeks of the clinical trial drug administration. - There is no involvement in soft tissue metastasis. 3. Persons who are receiving at least 3 months of endocrine therapy or bisphosphonate therapy and are expected not to change their treatment plan during the course of the study. 4. Before enrolling clinical trials, listen to the test person in sufficient detail for the purpose of the examination, the contents of the test, the characteristics of the test drug, etc., and the patient or the subject signed by the guardian or legal representative 5. Patients aged 19 to 80 years 6. The Eastern Cooperative Oncology Group (ECOG) _ Performance scale =2 7. Those who meet the following conditions in the blood test - absolute neutrophil count (ANC) = 1,500/µL - Platelet count (PLT) = 100,000/µL - hemoglobin = 10 g/dL (100g/L; 6.2 mmol /L)
Exclusion criteria
Exclusion criteria: 1. A person who is judged to be difficult to perform a clinical trial due to a serious medical condition 2. Visceral metastases as assessed 3. Those who are deemed to need chemotherapy within the next 6 months 4. Those who plan to change or plan to undergo new endocrine therapy or bisphosphonate treatment during the course of the study 5. Those who received chemotherapy, immunotherapy or external radiation therapy within 4 weeks of initiation of clinical studies 6. The person who is determined to have a mental disorder that is difficult to perform PET scan 7. Those participating in other clinical trials at screening, and those in clinical trials who may be involved in the acquisition of 18F-FDG or 18F-NaF PET images 8. Those who have participated in other clinical trials that may affect the acquisition of 18F-FDG or 18F-NaF PET images from the time of registration until the end of the study or that may affect the safety evaluation following intravenous injection of 223Ra. 9. Those who have the potential to influence the acquisition of 18F-FDG PET images due to unadjusted diabetes 10. If the pregnancy has been confirmed at the beginning of the clinical study, or if there is a possibility of pregnancy during the period of the clinical study 11. Who should breastfeed during the period of clinical research 12. Any other person who is deemed not to be eligible to participate in the trial 13. Vulnerable subjects (researchers or students who participated in the research, family members, researchers or students of researchers participating in research)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| standardized uptake value (SUV) of 18F-NaF PET;standardized uptake value (SUV) of 18F-FDG PET | — |
Secondary
| Measure | Time frame |
|---|---|
| ALP (alkaline phosphatase);osteocalcin | — |
Countries
Korea, Republic of
Contacts
Public ContactInki Lee
Korea Cancer Center Hospital
Outcome results
None listed