A Study of Elacestrant Alone or in Combination With Abemaciclib in People With Endometrial Cancer (NCT07209449) | Clinical Trial Compass
RecruitingPhase 2
A Study of Elacestrant Alone or in Combination With Abemaciclib in People With Endometrial Cancer
United States75 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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-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 ot…