Higher Dose Preoperative taMOxifen in Premenopausal bREast Cancer Patients

• Status: Not yet recruiting
• Trial end date: 2023-03-30
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Tamoxifen

Criteria

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, ANC 1,500/mm3, Plt 100,000/mm3

6. Patients with adequate kidney function

• serum Cr ≤ 1.5 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: ≤ 1.5 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, uterine myoma, unknown vaginal bleeding

9. Inability to understand and willingness to sign a written informed consent

10. Patients with endometriosis, uterine fibroids, 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