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Active, not recruiting Phase 2

Higher Dose Preoperative taMOxifen in Premenopausal bREast Cancer Patients

NCT04997941 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 2
Started
2021-10-21
Last updated
2024-04-23

Condition(s) studied

Premenopausal Breast CancerHormone Receptor-positive Breast Cancer

Investigational drug(s) / intervention(s)

Tamoxifen Oral ProductAssessment of Ki-67Surgery

Tamoxifen Oral Product: Experimental arm will have tamoxifen 40mg and active comparator arm will have tamoxifen 20mg for 14 days.

Assessment of Ki-67: Paired biopsies (before and after tamoxifen therapy) will be required for the assessment of Ki-67.

Surgery: The surgery date should be fixed before randomization. The surgery is to be performed within 1 day after the last dose of study treatment.

Study summary

MORE-T trial is designed to investigate the effect of Tamoxifen 40mg (vs. Tamoxifen 20mg) for 2wks in presurgical setting.

The greater reduction in Ki-67 might be observed in Tamoxifen 40mg arm compared to the Tamoxifen 20mg arm.

Open Label, Phase 2, Randomized with 1:1 allocation

Eligibility

Sex
FEMALE
Min age
20 Years
Max age
48 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Histopathologically and immunohistochemically confirmed ER+ and HER2- Premenopausal BC patients 2. Tumor size \>0.5cm on USG 3. Stage I-IIIA BC and planned curative surgery 4. ECOG 0-2 5. Patients with adequate bone marrow function \- Hemoglobin \> 10 g/dL, Plt \> 100,000/mm3 6. Patients with adequate kidney function \- serum Cr ≤ 1.4 mg/dL 7. Patients with adequate liver function * Bilirubin: ≤ 1.5 times of upper normal limit * AST/ALT: ≤ 1.5 times of upper normal limit * Alkaline phosphatase: ≤ 1.8 times of upper normal limit 8. Patients who decided to voluntarily participate in this trial with written informed consent 9. 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: 1. Previous history of ipsilateral invasive breast cancer, in situ lesion 2. Previous history of chemotherapy or endocrine therapy on contralateral BC for the past 2 years 3. Patients who has distant metastasis 4. Patients who is pregnant or breastfeeding 5. Hormon receptor negative BC 6. Her-2 positive BC 7. Diagnosed pituitary adenoma 8. Women who has endometriosis, unknown vaginal bleeding 9. Inability to understand and willingness to sign a written informed consent 10. Patients with endometriosis or unexplained vaginal bleeding 11. Patients with a history of bleeding constitution, coagulopathy, or thromboembolism 12. Patients who have administered a CYP3A inhibitor or inducer, CYP2D6 inhibitor, etc. within 4 weeks prior to randomization

Primary outcome measure(s)

  • Changes in Ki-67 level — After 14-day of tamoxifen treatment
    Change in Ki67 (percentage of positive tumor cells tested by immunohistochemistry \[IHC\] - digital Image Analysis ) after a 14-day treatment period compared to baseline.

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Hospital Seoul South Korea

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04997941 on ClinicalTrials.gov ↗ ← All trials in South Korea