Tokyo, Oct. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063177) titled 'Study of Ki67 assessment practices and patient characteristics in hormone receptor-positive, HER2-negative early breast cancer' on Oct. 5.

Study Type: Observational

Primary Sponsor: Institute - Showa Medical University

Condition: Condition - Hormone receptor-positive, HER2-negative early breast cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To describe real-world Ki67 assessment practices for HR-positive, HER2-negative early breast cancer in Japan and retrospectively characterize patient factors associated with recurrence risk using medical records. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Female Key inclusion criteria - 1. Female and aged 18 years or older at breast cancer diagnosis. 2. Histologically confirmed invasive breast cancer. 3. ER-positive or PgR-positive (at least 1% IHC-positive cells or Allred score at least 3). 4. HER2-negative (IHC 0/1+ or FISH/DISH negative). 5. Surgery as initial treatment for stage II-III HR-positive, HER2-negative breast cancer. 6. Standard adjuvant endocrine therapy started between 1 January 2017 and 31 December 2022. 7. Ki67 measured before adjuvant endocrine therapy, with a result available. Key exclusion criteria - 1. Missing medical-record data prevents collection of key study variables. 2. Treatment differs from standard care due to participation in a clinical trial during the target period, except for the monarchE trial. 3. Otherwise considered unsuitable by the physician. Target Size - 300

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 08 Month 03 Day Date of IRB - 2026 Year 10 Month 01 Day Anticipated trial start date - 2026 Year 11 Month 01 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071616

Disclaimer: Curated by HT Syndication.