Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058327) titled 'Holistic Analysis of Breast Cancer with BRCA1/2 Pathogenic Variants and Development of a Decision Aid for Risk-Reducing Mastectomy: BRCA-Decision study' on July 1.

Study Type: Observational

Primary Sponsor: Institute - Kyorin University

Condition: Condition - Breast Cancer Classification by malignancy - Malignancy Genomic information - YES

Objective: Narrative objectives1 - This study aims to elucidate the differences in health-related quality of life (HR-QOL) and decision-making factors associated with the implementation of contralateral risk-reducing mastectomy (CRRM) in patients with breast cancer carrying BRCA1/2 pathogenic variants, and to develop a high-quality decision aid to support surgical choices. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Female Key inclusion criteria - 1. Female patients diagnosed with primary breast cancer who were confirmed to carry BRCA1/2 pathogenic variants through genetic testing between April 1, 2020, and June 30, 2026, and for whom at least three months have passed since the diagnosis

2. No restrictions regarding the type of breast surgery, presence or absence of breast reconstruction, or use of adjuvant therapy

3. Women aged 20 years or older Key exclusion criteria - 1. Patients with de novo stage IV breast cancer or with recurrent breast cancer

2. Patients with synchronous bilateral breast cancer

3. Patients with metachronous bilateral breast cancer who have previously undergone total mastectomy on either side

4. Individuals carrying BRCA1/2 pathogenic variants without a history of breast cancer

5. Patients with active malignant diseases other than occult ovarian or fallopian tube cancer identified through risk-reducing salpingo-oophorectomy (RRSO)

6. Patients with severe psychiatric disorders

7. Patients deemed unsuitable for participation by the attending physician

8. Patients who decline to participate in the study Target Size - 600

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 05 Month 07 Day Anticipated trial start date - 2025 Year 07 Month 01 Day Last follow-up date - 2029 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066666

Disclaimer: Curated by HT Syndication.