Elacestrant with or without Abemaciclib for Endometrial Cancer
This study is looking at whether elacestrant, either alone or combined with abemaciclib, is a safe and effective treatment for people with advanced or recurrent endometrial cancer that is ER+ (estrogen receptor positive). To join, you must be at least 18 years old, have a good general health status (ECOG performance status of 0 or 1), and have previously received platinum-based chemotherapy. You also should not have had more than two prior treatments for your endometrial cancer. The researchers will measure how many people respond to the treatment after one year. The current recruitment status for this study is unclear.
- Study design
- This is an interventional study with a planned enrollment of 75 participants. The phase of the study is not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome, objective response rate, will be measured at 1 year.
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NCT07209449
A Study of Elacestrant Alone or in Combination With Abemaciclib in People With Endometrial Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~75 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:AbemaciclibElacestrant
At a glance
Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
objective response rate
Measured over 1 year
Conditions
Where it's being run
7 sites across 2 statesNew York4
New Jersey3
Study leadership
- Sminu Bose, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Measurable disease per RECIST v 1.1 criteria
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.
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
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:
Absolute neutrophil count ≥1500/mm3 (≥1.5 × 10\^3/μL)
Platelets ≥100,000/μL
Hemoglobin ≥9.0 g/dL
Creatinine clearance (CrCL) Creatinine clearance (CrCl) ≥ 50 mL/min using the Cockcroft-Gault formula
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)
Exclusion
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.
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.
What this trial measures
- objective response rate1 year
according to RECIST 1.1 criteria. Defined as the percentage of patients with complete response (CR) + partial response (PR)\] after initiating therapy.