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

What Was Tested

This registered phase 3 trial tested Goserelin.

It had three arms (groups): one (no intervention), one (no intervention) and one (active comparator).

Keep go on TMX.

Keep go on TMX.

OFS add on to TMX.

The registry classes the interventions as drug.

More on the Plan

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.

Analysis : 5yr MDR (1'endpoint), 5yr DFS(2'endpoint), 5yr OS 6.

Who Took Part

Enrollment: 224 planned participants were the target.

It was open to women only aged from 20 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Premenopausal women, ER+ breast cancer, stage I\~III, underwent standard treatment including surgery, Planned TMX. Available MMG density check via Volpara.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: bilateral breast cancer; prior endocrine therapy; postmenopausal status.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Goserelin and who got the comparison, which limits bias.

The Goserelin group and the comparison group ran side by side rather than switching.

Everyone knew when Goserelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2018-09-03 with completion listed for 2024-12-02.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Disease free survival.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 224 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Goserelin compound page, all human trials.