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Pilot clinical study of boron neutron capture therapy on post-radiotherapy, recurrent breast cancer (BNCTonrBC)

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

1

BNCT was applied for a case of refractory breast cancer recurred after operations, radiotherapy, chemotherapy and hormone therapy.

We canceled this clinical trial in the midway of the trial by the following reasons. Kyoto University Research Reactor did not work stably and stopped the clinical BNCT activity at the end of February, 2020.

Transient anorexia was observed (CTCAE grade 1).

1) The primary endpoint of this study was local control judged by CT measurement in accordance with RECIST 1.1 (Unit (mm): Sum of the long diameters of tumor lesions); Screening / 86.4 mm, BNCT 1M / 85.3mm, BNCT 2M / 66.8 mm, BNCT 4M / 59.2 mm, BNCT 6M / 60.8 mm, BNCT 9M / 73.7 mm. PD assessment was done 9 months after BNCT. 2) Non-target lesion appeared in this observation period.

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

April. 23, 2021

No

N/A

https://jrct.niph.go.jp/latest-detail/jRCTs051180219

Miyatake Shin-Ichi

(Affiliation) Osaka Medical College Kansai BNCT Medical Center (Medical Institutions) Osaka Medical College Hospital

2-7 Daigakumachi, Takatsuki, Osaka

neu070@osaka-med.ac.jp

Miyatake Shin-Ichi

Osaka Medical College Kansai BNCT Medical Center

2-7 Daigakumachi, Takatsuki, Osaka

+81-72-683-1221

neu070@osaka-med.ac.jp

Complete

Oct. 10, 2017

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

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.

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.

Female

Recurrent breast cancer after X-ray treatment

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.

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..

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).

+81-72-684-6760

Mar. 01, 2019

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