None listed
Conditions
Interventions
None listed
Sponsors
Yonsei University Health System, Gangnam Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Women between the ages of 35 and 50 2) Patients who satisfy one of the following conditions ? Pre-menopausal female, within 6 months of the last menstrual period ? Patients who have undergone hysterectomy or whose menopausal status is unclear, with a serum FSH level of less than 30mIU/mL 3) Patients diagnosed with breast cancer histopathologically and underwent surgery for curative purposes who have not yet started adjuvant chemotherapy or hormone therapy 4) Patients with negative resection margins who have undergone breast conserving surgery, planned radiation therapy, or have undergone total mastectomy 5) Patients with estrogen or progesterone receptor positive (=1%) on immunohistochemistry (IHC) 6) Patients who are HER2 negative (IHC 0, 1+; if 2+, FISH or SISH negative) according to ASCO/CAP guidelines 7) Patients with T-stage 1 or 2 after breast cancer surgery 8) Patients with pathological lymph node stage pN1 (pN1mi, pN1a, pN1b, pN1c) after sentinel lymph node biopsy or axillary lymph node clearing 9) Patients who have not performed other multigene tests (OncotypeDX, Mammaprint, Prosigna, EndoPredict, etc.) prior to study enrollment for breast cancer 10) Patients who can obtain tissues necessary for OncoFREE® examination (10 FFPE 10 µm slides: Unstained_10µm X 9, H&E_4µm X 1) 11) Patients with no clinically confirmed systemic metastases 12) Patients whose general performance status is 0-2 points based on ECOG (European Cooperative Oncology Group). Patients without mental, physical, or geographical problems for appropriate periodic follow-up. 13) Patients who signed the consent form before the start of the clinical trial Patients who signed the consent form before the start of the clinical trial
Exclusion criteria
Exclusion criteria: 1) Patients with a history of cancer diagnosis within 5 years: Excluding skin cancer and cervical cancer in situ (thyroid cancer is possible, but undifferentiated thyroid cancer is not possible) 2) age < 35 3) Patients who received prior chemotherapy or prior hormone therapy for breast cancer 4) Patients with inflammatory breast cancer, neuroendocrine tumor, or malignant phyllodes tumor 5) Patients with bilateral breast cancer 6) Patients who are deemed to require long-term systemic steroid therapy or immunosuppressive therapy 7) Patients who have previously undergone bilateral salpingo-oophorectomy 8) Patients who have previously received prophylactic tamoxifen or raloxifene 9) Patients who have previously received radiation therapy to the breast 10) Patients who are pregnant or lactating 11) Among subjects of childbearing potential, those who do not agree to contraception* in a medically accepted method during this clinical trial * Medically accepted methods of contraception: condoms, oral contraception continued for at least 3 months, use of injectable or implantable contraceptives, installation of intrauterine contraceptives, etc. 12) Those who have difficulty understanding the contents of the questionnaire and completing the questionnaire
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distant recurrence-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Distant recurrence-free survival;Invasive disease-free survival;Overall survival;Local disease-free interval;Quality of life | — |
Countries
Korea, Republic of
Contacts
Public ContactSung Gwe Ahn
Yonsei University Health System, Gangnam Severance Hospital
Outcome results
None listed