OncoMatch/Clinical Trials/NCT07209449
A Study of Elacestrant Alone or in Combination With Abemaciclib in People With Endometrial Cancer
Is NCT07209449 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Abemaciclib and Elacestrant for endometrial cancer.
Treatment: Abemaciclib · Elacestrant — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Endometrial Cancer
Biomarker criteria
Required: ESR1 overexpression (≥ 1% staining by IHC)
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
Required: TP53 wild-type
p53 wt by IHC or TP53 wt by next generation sequencing platform
Excluded: MMR deficient
No known dMMR
Excluded: POLE mutation
No known POLE mutation
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy
Patients must have received previous platinum-based chemotherapy
Must have received: anti-PD-1 therapy
Patients must have received previous...treatment with a PD-1 inhibitor
Cannot have received: CDK4/6 inhibitor
No prior treatment with a CDK4/6 inhibitor
Cannot have received: oral SERD (elacestrant)
Patients who have received prior treatment with elacestrant or other investigational oral SERD
Cannot have received: mTOR inhibitor (everolimus, temsirolimus, ridaforolimus)
Patients who have received prior treatment with...everolimus, temsirolimus, ridaforolimus or another mTOR inhibitor
Cannot have received: CDK4/6 inhibitor
Patients who have received prior treatment with...any CDK4 and CDK6 inhibitor
Lab requirements
Blood counts
Absolute neutrophil count ≥1500/mm3 (≥1.5 × 10^3/μL); Platelets ≥100,000/μL; Hemoglobin ≥9.0 g/dL
Kidney function
Creatinine clearance (CrCl) ≥ 50 mL/min using the Cockcroft-Gault formula
Liver function
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); 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 ≥3.0 g/dL (≥30 g/L)
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) ≥ 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); 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 ≥3.0 g/dL (≥30 g/L)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Basking Ridge · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth · Middletown, New Jersey
- Memorial Sloan Kettering Bergen · Montvale, New Jersey
- Memorial Sloan Kettering Commack · Commack, New York
- Memorial Sloan Kettering Westchester · Harrison, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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