Clinical trial · Interventional
Higher Dose Preoperative taMOxifen in Premenopausal bREast Cancer Patients
Higher Dose taMOxifen in Premenopausal bREast Cancer Patients: a preoperaTive Window Trial (MORE-T Trial)
NCT04997941CI-TRIAL-00076387MORE-Tactive not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone Receptor-positive Breast Cancer | — | UNRESOLVED | — |
| Premenopausal Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Assessment of Ki-67 | Diagnostic Test | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
| Tamoxifen Oral Product | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tamoxifen 40mg
- description
- Tamoxifen 20mg b.i.d - Participants will be treated for 14 days.
- interventionNames
- Drug: Tamoxifen Oral Product
- Diagnostic Test: Assessment of Ki-67
- Procedure: Surgery
- type
- ACTIVE_COMPARATOR
- label
- Tamoxifen 20mg
- description
- Tamoxifen 10mg b.i.d - Participants will be treated for 14 days.
- interventionNames
- Drug: Tamoxifen Oral Product
- Diagnostic Test: Assessment of Ki-67
- Procedure: Surgery
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 48 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.