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Recruiting Phase 2 NCT07209449

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

Trial Parameters

Condition Endometrial Cancer
Sponsor Memorial Sloan Kettering Cancer Center
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 75
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2025-10-01
Completion 2028-10-01
Interventions
AbemaciclibElacestrant

Brief 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 Criteria

Inclusion Criteria: * 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 °Adjuvant chemotherapy completed ≥ 12 months prior will not be counted toward prior therapy * Patients may have received ≤ one prior line of endocrine therapy for management of endometrial carcinoma. * No prior treatment with a CDK4/6 inhibitor * Measurable disease per RECIST v 1.1 criteria °Tumors within a previously irradiated field will be designated as "non-t

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