Density Lowering Effect of "OFS Add on to TMX"(DELFINO Trial)

Breast Cancer Invasive Clinical Trial

Official title:

Density Lowering Effect of Ovarian Function Suppression in Premenopausal Breast Cancer Patients Who Had no Density Change With One Year of Tamoxifen Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03664895
• Other study ID #: DELFINO trial
• Status: Recruiting
• Phase: Phase 3
• Start date: September 3, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Seoul National University Hospital
• Contact: Eun-Shin Lee
• Phone: 82-2-2072-0173
• Email: silvershoe99[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

DELFINO tial is designed to investigate the role of "OFS add on to TMX ", based on MMG density as a surrogate marker in premenopausal women - Premise - MMG density as a surrogate marker of hormone therapy - Assumption - "Add on OFS to TMX" would have further decrease of density - 3-arm(Observation arm + Randomised 2-arm), phase III, RCT with 1:1 allocation

Description:

Enroll : Sep03,2018~(Planned N= 224) 1. Inclusion criteria - Premenopausal - ER+ - Planned tamoxifen(TMX) - No planned ovary function suppression(OFS) - Regardless of ChemoTx - Mammography(MMG) density check via Volpara*(=Baseline MMG density, BaMD) (*Volpara= software to check MMG density) 2. Check MMG Density via Volpara After 1yr TMX (At1yrMD) Check menopausal status after 1yr TMX(Menstruation episode or FSH <30) 3. MMG Density Reduction(MDR =BaMD-AtMD ) at 1yr 4. MDR ≥5% -> Keep go on TMX MDR <5% -> 1:1 randomization -> Keep go on TMX vs OFS add on to TMX 5. Analysis : 5yr MDR (1'endpoint), 5yr DFS(2'endpoint), 5yr OS 6. Calculation of patients' number In previous study() MDR (Mammography Density Reduction) was found in about 50% of all patients who received endocrine therapy. Expected - MDR in "TMX only" cohort -> 6 ± 7% - MDR in "OFS add on to TMX" -> 10 ± 7% - after 1yr, Significance level 5%, average MDR 4% difference, 80% power, 10% dropout rate => 1:1 randomization Number = 112(56:56) Total number = 224

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: December 31, 2024
• Est. primary completion date: December 2, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Premenopausal women, ER+ breast cancer, stage I~III, underwent standard treatment including surgery, Planned TMX
• available MMG density check via Volpara

Exclusion Criteria:

• Bilateral breast cancer
• Prior endocrine therapy
• Postmenopausal status
• unavailable MMG density check via volpara before and after TMX

Related Conditions & MeSH terms

• Breast Cancer Invasive
• Breast Neoplasms

Intervention

Drug:
• Leuplin or zoladex
OFS(Leuplin or zoladex) add on to TMX

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	overall survival		5 years
Primary	MMG density Reduction		5 years
Secondary	Disease free survival		5 years