Hereditary Breast and Ovarian Cancer
Conditions
Interventions
Perform a risk-reducing mastectomy if the patient requests it.
Sponsors
Mie University hospital, breast center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Women aged 18 years or older who have undergone genetic counseling and have a BRCA1/2 gene mutation as a result of genetic diagnosis. 2) Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 3) To participate in this study, the patient's voluntary written consent has been obtained after sufficient informed consent, including explanation of alternative treatments. The decision was made based on the results of the genetic test and after thorough discussions with the patient and her family.
Exclusion criteria
Exclusion criteria: 1) Surgery is not possible after normal preoperative examinations 2) Patients who are pregnant or may become pregnant 3) Patients who are judged by the research director or co-investigator to be unsuitable as research subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of risk-reducing mastectomy (RRM) for BRCA1/2 gene mutation carriers Frequency of intraoperative and postoperative complications | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Latent Breast Cancer in RRM Resected Tissue Incidence of Breast Cancer on the RRM Side Within 2 Years Post-RRM Surgery | — |
Countries
Japan
Contacts
Public ContactMai Shibusawa
Mie University hospital breast center
Outcome results
None listed