Higher Dose taMOxifen in Premenopausal bREast Cancer Patients: a preoperaTive Window Trial

Seoul National University Hospital0 个研究点目标入组 80 人开始时间: 待定最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Histopathologically and immunohistochemically confirmed ER+ and HER2- Premenopausal BC patients
•Tumor size >0.5cm on USG
•Stage I-IIIA BC and planned curative surgery
•Patients with adequate bone marrow function : Hemoglobin 10 g/dL, ANC 1,500/mm3, Plt 100,000/mm3
•Patients with adequate kidney function : serum Cr = 1.5 mg/dL
•Patients with adequate liver function : Bilirubin: = 1.5 times of upper normal limit, AST/ALT: = 1.5 times of upper normal limit, Alkaline phosphatase: = 1.5 times of upper normal limit
•Patients who decided to voluntarily participate in this trial with written informed consent
•Premenopausal women : women who has not removed both ovaries, women who had menses in recent 1 year and FSH level is less than 30mIU/ml

•Previous history of ipsilateral invasive breast cancer, in situ lesion
•Previous history of chemotherapy or endocrine therapy on contralateral BC for the past 2 years
•Patients who has distant metastasis
•Patients who is pregnant or breastfeeding
•Hormon receptor negative BC
•Her-2 positive BC
•Diagnosed pituitary adenoma
•Women who has endometriosis, uterine myoma, unknown vaginal bleeding
•Inability to understand and willingness to sign a written informed consent
•Patients with endometriosis, uterine fibroids, or unexplained vaginal bleeding
•Patients with a history of bleeding constitution, coagulopathy, or thromboembolism
•Patients who have administered a CYP3A inhibitor or inducer, CYP2D6 inhibitor, etc. within 4 weeks prior to randomization

发起方