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Feasibility study of Risk Reducing Mastectomy for healthy BRCA1/2 mutation carriers

Feasibility study of Risk Reducing Mastectomy for healthy BRCA1/2 mutation carriers - Feasibility study of Risk Reducing Mastectomy for healthy BRCA1/2 mutation carriers

Status
Recruiting
Phases
Unknown
Study type
Unknown
Source
JPRN
Registry ID
JPRN-UMIN000047013
Enrollment
1
Registered
2022-03-01
Start date
2019-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary Breast and Ovarian Cancer

Interventions

None listed

Sponsors

Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Healthy BRCA1 / 2 gene mutation carrier 2. After genetic counseling at our hospital 3. Proven to have a BRCA1 or BRCA2 gene mutation 4. Women who are 20 years of age or older on the date of consent acquisition. 5. Fully understanding risk-reducing mastectomy and wish to have risk-reducing mastectomy. 6. ECOG Performance Status (PS) is 0 7. Those that retain the functions of major organs (bone marrow, heart, lungs, liver, kidneys, etc.) 1) White blood cells: 3000 / mm3 or more, less than 12,000 / mm3 2) Hemoglobin: 9.0 g / dl or more 3) Platelets: 100,000 / mm3 or more 4) Total bilirubin: less than 2.0 mg / dL 5) AST, ALT: Facility normal value upper limit x 2 or less 6) Serum creatinine: Within normal facility normal value x 1.5 7) ECG, vital capacity: Those with cardiopulmonary function that can be operated by general anesthesia The inspection data in 1) -7) above shall be within 60 days before the date of consent acquisition. 8. Written consent from the subject to participate in this study

Exclusion criteria

Exclusion criteria: 1. Have active cancer 2. Pregnant and lactating women 3. Have an infectious disease that requires systemic treatment 4. Researchers have determined that participation in this study is inappropriate

Design outcomes

Primary

MeasureTime frame
Safety of surgery

Countries

Japan

Contacts

Public ContactNoriko Maeda

Yamaguchi University Graduate School of Medicine Department of Gastroenterological, Breast and Endocrine Surgery

nsampei@yamaguchi-u.ac.jp0836222264

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026