Study of BNCT on recurrent breast cancer

Phase 1

Recruiting

• Conditions: D001943; breast cancer

• Registration Number: JPRN-jRCTs031220371
• Lead Sponsor: Kurosaki Hiromasa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1) Written consent for participation in this study has been obtained from the subject or a surrogate at the time consent is obtained.
2) The following patients with breast cancer
Patients with confirmed recurrence within or at the margins of the chest radiotherapy field and one or more measurable lesions according to RECIST guidelines (version 1.1)
Patients who have undergone radiotherapy for more than 6 months since their last radiotherapy treatment.
Patients who are not adversely affected by withdrawal of chemotherapy (including molecular-targeted agents) for more than 4 weeks prior to BNCT treatment.
Patients who are deemed capable of containing all active lesions within the irradiated area envisaged by BNCT
Patients with the longest diameter of the entire target lesion of 15 cm or less
Patients with lesions with a distance of 6 cm or less from the skin surface to the deepest part of the tumor
Patients with no evidence of serious cardiac complications on resting 12-lead ECG

Exclusion Criteria

1) Patients who have received more than 75 Gy of radiotherapy to the lesion area in the prior treatment of the target lesion.
2) Patients with active lesions/active overlapping cancers other than the target lesion (however, patients with distant metastases who show no tendency to enlarge and whose quality of life can be significantly improved by controlling locally recurrent lesions are not excluded)
3) Patients with measurable tumor skin exposure greater than 5 cm
4) Patients with NYHA cardiac function classification grade III or IV
5) Patients with pulmonary fibrosis or interstitial pneumonia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety: Acute adverse events for safety evaluation criteria

Secondary Outcome Measures

Name	Time	Method
Efficacy: response rate, tumor shrinkage rate, progression-free survival, overall survival