Higher Dose Preoperative taMOxifen in Premenopausal bREast Cancer Patients

NCT04997941 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: MORE-T trial
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Premenopausal Breast Cancer; Hormone Receptor-positive Breast Cancer

Keywords

Premenopausal Breast Cancer; Ki-67; Hormone Receptor-positive Breast Cancer; Tamoxifen

Outcome Measures

Primary Outcomes (1)

• Changes in Ki-67 level

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

  After 14-day of tamoxifen treatment

Secondary Outcomes (7)

• Changes in Ki67 according to CYP2D6 genotyping

  After 14-day of tamoxifen treatment

• The proportion of participants with relative decrease from baseline of Ki-67 ≥50%

  After 14-day of tamoxifen treatment

• AE

  After 14-day of tamoxifen treatment

• SAE

  After 14-day of tamoxifen treatment

• PEPI (Preoperative Endocrine Prognostic Index) score

  After 14-day of tamoxifen treatment

Study Arms (2)

Tamoxifen 40mg

EXPERIMENTAL

Tamoxifen 20mg b.i.d - Participants will be treated for 14 days.

Drug: Tamoxifen Oral Product; Diagnostic Test: Assessment of Ki-67; Procedure: Surgery

Tamoxifen 20mg

ACTIVE COMPARATOR

Tamoxifen 10mg b.i.d - Participants will be treated for 14 days.

Drug: Tamoxifen Oral Product; Diagnostic Test: Assessment of Ki-67; Procedure: Surgery

Interventions

Tamoxifen Oral Product DRUG

Experimental arm will have tamoxifen 40mg and active comparator arm will have tamoxifen 20mg for 14 days.

Also known as: Tamoxifen 40mg vs. 20mg

Tamoxifen 20mg; Tamoxifen 40mg

Assessment of Ki-67 DIAGNOSTIC_TEST

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

Tamoxifen 20mg; Tamoxifen 40mg

Surgery PROCEDURE

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

Tamoxifen 20mg; Tamoxifen 40mg

Eligibility Criteria

• Age: 20 Years - 48 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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, Plt \> 100,000/mm3
• Patients with adequate kidney function
• \- serum Cr ≤ 1.4 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: ≤ 1.8 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

You may not qualify if:

• 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, unknown vaginal bleeding
• Inability to understand and willingness to sign a written informed consent
• Patients with endometriosis 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

Tamoxifen; Surgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Hyeong-Gon Moon

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 10, 2021
• Study Start: October 21, 2021
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

KR (1)