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

Phase 3

Recruiting

• Conditions: Breast Cancer Invasive
• Interventions: Drug: Leuplin or zoladex

• Registration Number: NCT03664895
• Lead Sponsor: Seoul National University Hospital

Brief 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

Detailed 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(\<Kim et al. Breast Can Res 2012\>) 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

Study Timeline

• Study Start: 2018-09-03
• Study First Submitted: 2018-09-07
• Study First Submitted QC: 2018-09-07
• Study First Posted: 2018-09-11
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-04
• Primary Completion: 2024-12-02
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OFS add arm(TMX + OFS, MDR<5%)	Leuplin or zoladex	OFS add on to TMX

Primary Outcome Measures

Name	Time	Method
MMG density Reduction	5 years

Secondary Outcome Measures

Name	Time	Method
Disease free survival	5 years

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of