Boron neutron capture therapy for recurrent and refractory breast cancer after X-ray treatment

Phase 2

• Conditions: Recurrent breast cancer after X-ray treatment

• Registration Number: JPRN-jRCTs051180219
• Lead Sponsor: Miyatake Shin-Ichi

Brief Summary

BNCT could locally control the lesion transiently locally in a case of recurrent and refractory breast cancer case.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-27
• Study Completion: 2020-05-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 1

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 months.
4. Chemotherapy (including molecular targeting agent) 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 in diagnostic imaging.
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, serum creatinine less than 1.2 mg/dl, albumin 3.5mg/dl or more, LDH less than 240 IU /L.
9. If there are metastatic lesions, they should be controlled well by chemotherapy and so on.
10. Written informed consent should be obtained from the patients for this clinical trial.

Exclusion Criteria

1. Complication of congestive heart failure of III degree or more in NYHA
2. Patients who have 3 or more metastatic organs.
3. Patients who have uncontrollable brain or lever metastasis.
4. Pregnant woman or lactating woman
5. Patients with phenylketonuria
6. Measurable exposed skin lesion more than 5cm (excluding skin ulcer derived from metastatic skin lesion from breast cancer or derived from inflammatory breast cancer).
7. Patients who have mental illness and judged as difficult for participation of this clinical trial.
8. Patients who have infectious disease which is necessary for the treatment.
9. Pulmonary fibrosis or interstitial pneumonia.
10. Patients who have the broader lesion on the skin more than 5 cm in diameter.
11. Patients who are judged to be inappropriate for participation in this study by an investigator or a test sharing physician for other reasons.

Study & Design

• Study Type: Interventional
• Study Design: Not specified