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

JRCT ID: jRCTs051180219

Registered date:27/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Recurrent breast cancer after X-ray treatment
• Date of first enrollment: 03/08/2018
• Target sample size: 3
• Study type: Interventional
• Intervention(s): 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 exposure. Neutron irradiation time is decided to apply 1.5 x 10+E12 n/cm2 neutron as flux on skin.

Outcome(s)

Primary Outcome

Local control:
The lesions should be measured on MR or CT. If it is
immpossible to measure from the images, the lesions should be measured directly on the skin periodically. The assessment of local control should be judged from RECIST v.1.1..

Secondary Outcome

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).

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Female

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Miyatake Shin-Ichi
• Secondary ID(s): UMIN000029403