Tokyo, March 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060989) titled 'Study of real-world treatment before and after surgery for people with HER2-positive breast cancer' on March 24.
Study Type:
Observational
Primary Sponsor:
Institute - Prime Research Institute for Medical RWD, Inc.
Condition:
Condition - HER2-positive breast cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To describe perioperative treatment patterns and treatment outcomes in HER2-positive breast cancer patients stratified by stage using J-CONNECT registry data.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Newly diagnosed with breast cancer between 2018-10-01 and 2024-09-30; 2. Age 18 years or older at diagnosis; 3. Clinical stage I-IIIc at diagnosis; 4. HER2 positivity confirmed at any time during treatment; 5. Breast malignant tumor surgery performed by 2024-09-30.
Key exclusion criteria - Record of diagnosis of a non-breast cancer before the diagnosis of breast cancer.
Target Size - 4000
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 04 Day
Date of IRB - 2026 Year 03 Month 18 Day
Anticipated trial start date - 2026 Year 03 Month 27 Day
Last follow-up date - 2026 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069791
Disclaimer: Curated by HT Syndication.
