Tokyo, Nov. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059883) titled 'Observational Study on the Efficacy and Safety of Accelerated Partial Breast Irradiation after Breast-Conserving Surgery' on Nov. 26.
Study Type:
Observational
Primary Sponsor:
Institute - St. Luke's International University
Condition:
Condition - Breast cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To prospectively investigate the implementation status and outcomes of accelerated partial breast irradiation in patients after breast-conserving surgery, and to clarify its efficacy and safety.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 40
years-old
Gender - Female
Key inclusion criteria - Invasive breast cancer:
Tumor size 3cm or less
No lymphnode metastasis
No lymphovascular invasion
Negative surgical margins
Ductal carcinoma in situ:
Tumor size 3cm or less
Negative surgical margins
Key exclusion criteria - Invasive lobular carcinoma
Known pathogenic variants in breast cancer susceptibility genes (BRCA) 1/2
Target Size - 180
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 06 Month 06 Day
Date of IRB - 2025 Year 06 Month 11 Day
Anticipated trial start date - 2025 Year 07 Month 16 Day
Last follow-up date - 2032 Year 07 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068487
Disclaimer: Curated by HT Syndication.