Recruiting

Elacestrant and Abemaciclib for ER+ Endometrial Cancer

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What is being tested

Abemaciclib

+ Elacestrant
Drug
Who is being recruted

Endometrial Cancer

Over 18 Years
+64 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2025

See protocol details

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center
Study ContactAngela Green, MD
Last updated: October 7, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2025Actual date on which the first participant was enrolled.

This study explores the effectiveness and safety of a drug called elacestrant, either on its own or combined with another drug called abemaciclib, for people diagnosed with advanced or recurring estrogen receptor-positive endometrial cancer. This type of cancer relies on estrogen to grow, and the study focuses on patients whose tumors have a normal p53 gene, which is often associated with better outcomes. By finding better treatment options for this specific group of patients, the study aims to improve care for those who have few effective treatment choices currently. Participants in the study will receive either elacestrant alone or a combination of elacestrant and abemaciclib. The medications may be administered orally, and researchers will monitor the participants to evaluate the drugs' effectiveness in controlling the cancer and any side effects they may experience. The study does not specify primary outcomes, but it will likely look at factors such as tumor response to treatment and the overall safety of the drugs.

Official TitlePhase II Study of ELacestrant in Combination With Abemaciclib or Elacestrant Alone In p53 Wild Type, Estrogen Receptor-positive Advanced or recurrenT Endometrial Cancer (ELITE) 
Principal SponsorMemorial Sloan Kettering Cancer Center
Study ContactAngela Green, MD
Last updated: October 7, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
75 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Endometrial Cancer
Criteria
38 inclusion criteria required to participate
Age ≥18 years at the time of informed consent
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Patients must have received previous platinum-based chemotherapy and treatment with a PD-1 inhibitor, together or separately, prior to enrolling on this trial
Patients may have received no more than 1 prior line of chemotherapy for management of endometrial carcinoma. This includes platinum-based chemotherapy alone or combined with a PD-1 inhibitor, small molecule agents, and chemotherapy in combination with radiation therapy. A washout period of 14 days is required for chemotherapy

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26 exclusion criteria prevent from participating
Patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to randomization, or is currently enrolled in any other type of medical research not scientifically or medically compatible with this study
Patient who is experiencing a visceral crisis, lymphangitic disease spread, leptomeningeal carcinomatosis. Visceral crisis is not the mere presence of visceral metastases but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of disease
Patients who have received prior treatment with elacestrant or other investigational oral SERD, everolimus, temsirolimus, ridaforolimus or another mTOR inhibitor, or any CDK4 and CDK6 inhibitor
Patients with hyperlipidemia that is not adequately controlled

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Patients receiving both drugs should take elacestrant orally once daily with abemaciclib orally in the morning and abemaciclib orally only in the evening at the same time every day.
Group II
Experimental
Patients receiving elacestrant only should take orally once daily in the morning.
Study Objectives
Primary Objectives

according to RECIST 1.1 criteria. Defined as the percentage of patients with complete response (CR) + partial response (PR)\] after initiating therapy.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 7 locations
Recruiting
Memorial Sloan Kettering Basking RidgeBasking Ridge, United StatesSee the location
Recruiting
Memorial Sloan Kettering MonmouthMiddletown, United States
Recruiting
Memorial Sloan Kettering BergenMontvale, United States
Recruiting
Memorial Sloan Kettering CommackCommack, United States
Recruiting
7 Study Centers