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

Not Applicable

Active, not recruiting

Conditions: Neoplasms

Registration Number: KCT0006681

Lead Sponsor: Seoul National University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Active, not recruiting

Sex: All

Target Recruitment: 80

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
ECOG 0-2
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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Ki67 (percentage of positive tumor cells tested by immunohistochemistry [IHC] - digital Image Analysis ) after a 14-day treatment period compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Change in Ki67 (percentage of positive tumor cells tested by immunohistochemistry [IHC]) after a 14-day treatment period compared to baseline according to CYP2D6 genotyping.;adverse event;severe adverse event ;The PEPI score (ranged 0 to 12, lower score mean a better outcome) is the sum of the risk points of the pathological tumor (pT) stage, the pathological node (pN) stage, Ki67 levels and ER status (Allred score).