KCT0008513尚未招募Unknown
Multi-center, Single-arm, Prospective cohort, Pilot study, Investigator initiated clinical performance study to evaluate treatment response of endocrine therapies with ovarian function suppression in premenopausal node-positive breast cancer patients with low genomic risk group using OncoFREE
Yonsei University Health System, Gangnam Severance Hospital0 个研究点目标入组 604 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 604
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 35(Year) 至 50(Year)（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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