Post-radiotherapy, recurrent breast cancer
Conditions
Interventions
BNCT for patients with post-radiotherapy, recurrent breast cancer is applied by nuclear reactor. Lithium shield should be used during neutron irradiation to protect elements in orbit from neutron expo
Sponsors
Osaka Medical College
Kyoto University Research Reactor Institute
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients who are diagnosed histologically as breast cancer 2. Patients who have the one measurable recurrent lesion at least in the previous radiation treatment field. 3. The lesions were well controlled at once by surgery or previous irradiation more than 6 monhs. 4. Chemotherapy or hormone therapy should have been started already. Anti-HER2 agent can be stopped with more than 4 weeks interval. 5. The deepest lesion should be within 8 cm in depth. 6. Patients should be older than 20 and younger than 75 years old at informed consent. 7. ECOG Performance Status should be 0 or 1. 8. Patients with bone marrow, liver, kidney function satisfying the following conditions within 28 days before enrollment - Leukocyte count 3,000 /microlitter or more, Hemoglobin 8.0 g/dL or more, Platelet count 100,000 /microlitter or more, AST 100 IU/L or less, ALT 100 IU/L or less
Exclusion criteria
Exclusion criteria: 1. Complication of congestive heart failure of III degree or more in NYHA 2. Patients who have 3 or more metastatic lesions. 3. Patients who have uncontrollable brain or lever metastasis. 4. Pregnant woman or lactating woman 5. Patients with phenylketonuria 6. Patients who have mental illness and judged as difficult for participation of this clinical trial. 7. Patients who have infectious disease which is necessary for the treatment. 8. Pulmonary fibrosis or interstitial pneumonia. 9. Patients who have the broader lesion on the skin more than 5 cm in diameter. 10. Patients who are judged to be inappropriate for participation in this study by an investigator or a test sharing physician for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local control: The lesions should be measured on MR or CT or directly on the skin periodically. Major and minor axis should be recorded and judged as CR, PR, SD and PD for the assessment of local control, based on RECIST v.1.1.. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expression of adverse events Evaluate adverse events and serious adverse events. Observed adverse events are evaluated based on Common Toxicity Criteria for Adverse Events v4.0 (CTCAE v4.0). | — |
Countries
Japan
Contacts
Public ContactShin-Ichi Miyatake
Osaka Medical College Cancer Center
Outcome results
None listed