A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovarian Function Suppression (LHRH Agonist) in Premenopausal Patients With Stage I-II ER+/HER2- Breast Cancer

What Was Tested

This registered phase 2 trial tested Leuprolide.

This preoperative study will enroll consecutive patients with early stage HR+ BC who are not candidates for neoadjuvant chemotherapy but are eligible for short-term preoperative treatment with elacestrant, with or without leuprorelin, followed by breast surgery.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 140 planned participants were the target.

It was open to women only aged from 18 years with no upper age limit.

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

Examples of who could join: Aged 18 or more. Patients must be affiliated to a Social Security System (or equivalent). Available pre-treatment tru-cut biopsy evaluable. Absolute neutrophil count ≥ 1.0 x 109/L. Platelet count ≥ 75 x 109/L.

The full record lists 22 inclusion and 20 exclusion criteria; among the exclusions: patients non-candidate for upfront breast surgery or candidate for neoadjuvant chemotherapy; any systemic therapy (e.g, chemotherapy, targeted therapy, immune-therapy) or radiotherapy for current bc before study entry; prior treatment with lhrh-agonists over the last 6 months prior to the icf signature.

How the Study Was Run

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

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.

It started in 2025-10-06 with completion listed for 2027-01-29.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 9 secondary outcomes, for example Objective Response Rate, Rate of pathological of partial and complete response, Levels of estradiol, Levels of follicle-stimulating hormone (FSH), Levels of luteinizing hormone (LH) and Incidence of treatment-emergent AEs.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 140 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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