RecruitingPhase 2NCT07209449

A Study of Elacestrant Alone or in Combination With Abemaciclib in People With Endometrial Cancer

A Phase II, Randomization, Unblinded Study of ELacestrant in Combination With Abemaciclib or Elacestrant Alone In p53 Wild Type, Estrogen Receptor-positive Advanced or recurrenT Endometrial Cancer (ELITE)


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

75 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The researchers are doing this study to find out whether elacestrant is an effective and safe treatment alone or in combination with abemaciclib for people with advanced or recurrent ER+ endometrial cancer.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests two hormone-targeting drugs — Elacestrant (alone) and Elacestrant combined with Abemaciclib (a cell cycle inhibitor) — for people with advanced or recurring endometrial (uterine) cancer that has hormone-sensitive characteristics. **You may be eligible if...** - You are 18 or older - You have advanced or recurrent endometrial cancer - You have already received platinum-based chemotherapy and an immunotherapy (PD-1 inhibitor) at some point - You are in good overall health (ECOG score 0 or 1) - Your tumor has certain hormone receptor characteristics (as determined by your oncologist) **You may NOT be eligible if...** - You have received more than 1 prior line of chemotherapy for your endometrial cancer - You have had more than 1 prior line of hormonal therapy - You have active brain metastases - Your organ function (liver, kidneys, blood counts) does not meet required thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAbemaciclib

orally only in the evening

DRUGElacestrant

orally once daily in the morning


Locations(7)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07209449


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