HBOC
Conditions
Interventions
None listed
Sponsors
Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1 BRCA1 / 2 gene mutation-positive unilateral breast cancer patients with no suspected breast cancer in healthy breast and BRCA1 / 2 genetic mutation-positive unilateral breast cancer patients with no suspected breast cancer in contralateral healthy breast 2 The patient who has already been given genetic counseling 3 The patient who has been proven to have a BRCA1 or BRCA2 gene mutation 4 The patient with no suspicious findings of metastasis or recurrence of obvious breast cancer 5 Patients who understand risk-reducing mastectomy and wish to have risk-reducing mastectomy 7 The patient who retains 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: Patients with cardiopulmonary function who can operate with 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 9) Women who are 20 years or older on the date of consent acquisition
Exclusion criteria
Exclusion criteria: 1) The patient with cancer other than active primary early stage breast cancer (regardless of history of breast cancer or ovarian cancer) 2) Pregnant and lactating women 3) The patient with an infectious disease requiring systemic treatment 4) Bilateral breast cancer patients 5) The patient who the researcher deems inappropriate to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of Surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Confirm the presence of breast cancer lesions in the resected mammary gland | — |
Countries
Japan
Contacts
Public ContactNoriko Maeda
Yamaguchi University Graduate School of Medicine Department of Gastroenterological, Breast and Endocrine Surgery
Outcome results
None listed