Endometrial CancerPhase 2NCT07209449
A Study of Elacestrant Alone or in Combination With Abemaciclib in People With Endometrial Cancer
A Phase 2 study testing Abemaciclib and Elacestrant in people with Endometrial Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Abemaciclib and Elacestrant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Oct 2025to 1 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Patients may have received no more than 2 prior lines of therapy for management of endometrial carcinoma. This includes platinum-based chemotherapy alone or combined with a PD-1 inhibitor, small molecule agents, hormone therapy ,and chemotherapy in combination with radiation therapy. A washout period of 14 days is required for chemotherapy °Adjuvant chemotherapy completed ≥ 12 months prior will not be counted toward prior therapy
- Patients may have received a maximum of one prior line of endocrine therapy for management of endometrial carcinoma but no prior oral SERD such as elacestrant.
- No prior treatment with a CDK4/6 inhibitor
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- Measurable disease per RECIST v 1.1 criteria
- °Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented, or a biopsy is obtained to confirm persistence of tumor ≥ 90 days following completion of radiation therapy.
- Advanced or recurrent endometrial carcinoma that is refractory to curative therapy.
- Patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, de-differentiated, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma.
- Patient must have ER-positive tumor status either from the most recent sample of advanced/recurrent disease or from an archival tissue.
- °Documentation of ER-positive tumor with ≥ 1% staining by IHC as defined in the 2010 or 2020 American Society for Clinical Oncology recommendations for ER testing (Hammond 2010, Allison 2020)
- p53 wt by IHC or TP53 wt by next generation sequencing platform either from the most recent sample of advanced/recurrent disease or from an archival tissue.
- No known dMMR or POLE mutation
- If MSK IMPACT mutational profiling or mutational profiling performed in a CLIA laboratory is not already performed, must have tissue available for MSK IMPACT molecular profiling to be performed clinically
- Female patients may be either postmenopausal or premenopausal or perimenopausal. Postmenopausal status is defined by:
- Age ≥ 60 years
- Age < 60 years and amenorrhea for ≥12 months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) or a follicle-stimulating hormone value >40 mIU/mL and an estradiol value <40 pg/mL or in postmenopausal ranges per local reference ranges
- Documentation of prior bilateral oophorectomy, at least 1 month before first dose of trial therapy.
- Premenopausal or perimenopausal patients must be concurrently given a luteinizing hormone-releasing hormone (LHRH) agonist for ovarian suppression starting at least 4 weeks before the start of trial therapy and continue LHRH agonist during the study.
- The effects of elacestrant and abemaciclib on the developing human fetus are unknown. For this reason and because SERDs and CDK4/6 inhibitors as well as other therapeutic agents used in this trial are known to be teratogenic, participants of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) within 28 days of the first dose of study therapy, during study therapy, and for 120 days following the completion of study therapy. Should a participant become pregnant or suspect pregnancy while participating in this study, they should inform their treating physician immediately
- °Highly effective and low user dependency, non-hormonal contraception methods include: i. Intrauterine device (non-hormonal). ii. Total abstinence iii. Bilateral tubal occlusion/ligation. iv. Have a vasectomized partner (sole sexual partner) with confirmed azoospermia
- Any prior radiotherapy directed at the malignant tumor must be discontinued prior to first study treatment. Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between the end of radiotherapy and randomization.
- Have adequate laboratory values as defined below:
- °Hematologic
- Absolute neutrophil count ≥1500/mm3 (≥1.5 × 10^3/μL)
- Platelets ≥100,000/μL
- Hemoglobin ≥9.0 g/dL
- °Renal
- Creatinine clearance (CrCL) Creatinine clearance (CrCl) ≥ 50 mL/min using the Cockcroft-Gault formula
- °Hepatic
- Total bilirubin ≤1.5 ×ULN (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled)
- AST and ALT ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
- Coagulation Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 x ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy or due to prophylactic coagulation)
- Serum Albumin Serum albumin ≥3.0 g/dL (≥30 g/L)
Who cannot join
- 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 oral SERD, everolimus, temsirolimus, ridaforolimus or another mTOR inhibitor, or any CDK4 and CDK6 inhibitor
- Patients with hyperlipidemia that is not adequately controlled.
- Patients with history of interstitial lung disease (ILD)/pneumonitis or evidence of ILD/pneumonitis on baseline imaging.
- Uncontrolled significant active infections. °HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
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- control). Patients with a history of treated CNS metastases are eligible, provided that they meet all of the following criteria For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Females who are pregnant or nursing. If with childbearing potential, should have a negative urine pregnancy test at the time of screening.
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
- Major surgery within 4 weeks of randomization
- Inability to take oral medication, or history of malabsorption syndrome or any other uncontrolled gastrointestinal condition.
- Known intolerance to either study drug or any of the excipients.
- Any severe medical or psychiatric condition that in the opinion of the investigator(s) would preclude the patient's participation in a clinical study.
- Uncontrolled hypomagnesemia or hypokalemia, defined as values below the lower limit of normal despite optimal electrolyte supplementation or management
- Known untreated or active central nervous system (CNS) metastases (progression or requiring anticonvulsants or corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible, provided that they meet all of the following criteria:
- Presence of measurable disease outside the CNS
- No radiographic evidence of worsening upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study
- No history of intracranial hemorrhage or spinal cord hemorrhage
- No ongoing requirement for dexamethasone as therapy for CNS disease (anticonvulsants at a stable dose are allowed)
- Screening CNS radiographic study is within 6 months after most recent intervention for CNS metastases and greater than 4 months after discontinuation of corticosteroids
- Inability to comply with study and follow-up procedures
- Patient is currently receiving or received any of the following medications prior to first dose of trial therapy:
- Known strong or moderate inducers or inhibitors of cytochrome P450 (CYP) 3A4 (including foods and herbal preparations) within 14 days or 5 half-lives, whichever is shorter, prior to initiating study therapy.
- Herbal preparations/medications. These include, but are not limited to, St.John's wort, kava, ephedra (ma huang), ginkgo biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng within 21 days prior to initiating trial therapy
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Vicky Makker, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Sminu Bose, MD, 646-888-5427
- Recruiting
Memorial Sloan Kettering Commack
Commack, New York, 11725
Sminu Bose, MD, 646-888-5427
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Sminu Bose, MD, 646-888-5427
- Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Sminu Bose, MD, 646-888-5427
- Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Sminu Bose, MD, 646-888-5427
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Sminu Bose, MD, 646-888-5427
- Recruiting
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
Sminu Bose, MD, 646-888-5427
About this study
Official title: 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)
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.
- Conditions
- Endometrial Cancer
- Being tested
- Abemaciclib, Elacestrant
- Keywords
- Elacestrant, Abemaciclib, p53 Wild Type, Estrogen Receptor-positive, Advanced or Recurrent, 25-164
- Medical subject headings
- Endometrial Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbemaciclibDrug
orally only in the evening
ElacestrantDrug
orally once daily in the morning
| Study group | Role | What they receive |
|---|---|---|
| Abemaciclib plus Elacestrant | 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. Receives: Drug: Abemaciclib; Drug: Elacestrant |
| Elacestrant alone | Experimental | Patients receiving elacestrant only should take orally once daily in the morning. Receives: Drug: Elacestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
according to RECIST 1.1 criteria. Defined as the percentage of patients with complete response (CR) + partial response (PR)] after initiating therapy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Oct 2025
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a phase 2 single institution parallel two-arm randomized trial
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sminu Bose, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209449
- Sponsor's protocol ID
- 25-164
- Status last verified
- Jul 2026
- First submitted
- 1 Oct 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07209449
- Acronym / sponsor ID
- 25-164
- Conditions
- Endometrial Cancer
- Keywords
- Elacestrant, Abemaciclib, p53 Wild Type, Estrogen Receptor-positive, Advanced or Recurrent, 25-164
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a phase 2 single institution parallel two-arm randomized trial
| Arm | Type | Receives |
|---|---|---|
| Abemaciclib plus Elacestrant | Experimental | Drug: Abemaciclib, Drug: ElacestrantPatients 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. |
| Elacestrant alone | Experimental | Drug: ElacestrantPatients receiving elacestrant only should take orally once daily in the morning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (35 listed)
- 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
- Patients may have received no more than 2 prior lines of therapy for management of endometrial carcinoma. This includes platinum-based chemotherapy alone or combined with a PD-1 inhibitor, small molecule agents, hormone therapy ,and chemotherapy in combination with radiation therapy. A washout period of 14 days is required for chemotherapy °Adjuvant chemotherapy completed ≥ 12 months prior will not be counted toward prior therapy
- Patients may have received a maximum of one prior line of endocrine therapy for management of endometrial carcinoma but no prior oral SERD such as elacestrant.
Key exclusion criteria (26 listed)
- 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 oral SERD, everolimus, temsirolimus, ridaforolimus or another mTOR inhibitor, or any CDK4 and CDK6 inhibitor
- Patients with hyperlipidemia that is not adequately controlled.
- Patients with history of interstitial lung disease (ILD)/pneumonitis or evidence of ILD/pneumonitis on baseline imaging.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abemacicliborally only in the evening | Drug | Abemaciclib plus Elacestrant |
| Elacestrantorally once daily in the morning | Drug | Abemaciclib plus Elacestrant, Elacestrant alone |
Primary outcome
objective response rate
Time frame: 1 year
according to RECIST 1.1 criteria. Defined as the percentage of patients with complete response (CR) + partial response (PR)] after initiating therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vicky Makker, MD contact
Sminu Bose, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abemaciclib and Elacestrant in people with Endometrial Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 35 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sminu Bose, MD (646-888-5427, boses1@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.