KCT0006681Active, not recruiting未知
Higher Dose taMOxifen in Premenopausal bREast Cancer Patients: a preoperaTive Window Trial
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Active, not recruiting
- Enrollment
- 80
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 20(Year) to 48(Year) (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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