Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer

What Was Tested

In this phase 2 trial, researchers set out to test Triptorelin.

It had three arms (groups): Elacestrant (experimental), Elacestrant + Triptorelin (active comparator) and Tamoxifen (active comparator).

Without ovarian function suppression.

With ovarian function suppression.

Monotherapy.

The registry classes the interventions as drug.

More on the Plan

PremiÈRe Part A and Part B are parallel, non-comparative, two-arm, randomized 1:1, open-label, multicenter, exploratory trials designed to evaluate the biological activity of elacestrant in premenopausal women with primary operable HR+/HER2- BC.

An FFPE tumor sample of sufficient quality must be available, if not, patients must agree to undergo a re-biopsy.

During the treatment period, blood samples will be collected for the isolation of plasma and serum at baseline, Day 14, Day 28, and post-treatment.

In PremiÈRe Part B only, optional transvaginal ultrasound (TVUS) assessments may be performed at baseline, Day 28, and at the End of Study visit, to explore changes in ovarian and uterine parameters.

Who Took Part

96 planned participants were the target.

It was open to women only aged from 35 years with no upper age limit.

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

Examples of who could join: Signed informed consent must be obtained prior to any trial-specific procedure. Female patients who are at least 35 years of age on the day of signing informed consent. Patient is premenopausal at the time of study entry. Patient had last menstrual period within the last 6 months. OR. Plasma estradiol and FSH in the premenopausal range, according to local laboratory definition.

The full record lists 34 inclusion and 26 exclusion criteria; among the exclusions: patients requiring immediate neoadjuvant chemotherapy or immediate surgical intervention; patients who have undergone sentinel lymph node biopsy or tumor excisional biopsy prior to study treatment; patients currently on following medications, which cannot be interrupted 7 days prior treatment start:.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Triptorelin group and the comparison group should start out alike.

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

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

It started in 2023-02-03 with completion listed for 2026-12.

It ran at 15 sites in Spain (15).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: To evaluate the biological activity of elacestrant with or without OFS in premenopausal women with ER+/HER2- operable EBC (time frame: After 30 days (+7 days) of therapy).

It also tracked 8 secondary outcomes, for example To evaluate the antiproliferative activity of elacestrant with or without OFS after -treatment, To evaluate the effect of optimal and suboptimal OFS (E2 level greater than 2.72 pg/mL) in CCCA, To evaluate levels of E2 in blood, To evaluate levels of FSH in blood, To evaluate the safety of the treatments when administered in pre-menopausal patient population and To evaluate the tolerability of the treatments when administered in pre-menopausal patient population.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Triptorelin in 96 people.

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

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