Jonsson Comprehensive Cancer Center
This phase II trial tests how well elacestrant with everolimus works for the treatment of estrogen receptor (ER) positive endometrial cancer that has come back after a period of improvement (recurrent), that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Estrogen can cause the growth of cancer cells. Elacestrant lowers the amount of estrogen made by the body. This may help stop the growth of cancer cells that need estrogen to grow. Everolimus is in a class of medications called kinase inhibitors. It is also a type of angiogenesis inhibitor. Everolimus works by stopping cancer cells from reproducing and by decreasing blood supply to the cancer cells. Giving elacestrant with everolimus may be effective for treating patients with recurrent, advanced or metastatic ER positive endometrial cancer.
PRIMARY OBJECTIVE: I. To obtain an estimate of the proportion of patient's progression-free at 24 weeks (24-week PFS rate) with estrogen receptor positive (ER+) endometrial cancer following treatment with elacestrant and everolimus. SECONDARY OBJECTIVE: I. To assess clinical benefit rate (CBR) where clinical benefit is defined as achieving a confirmed objective response (complete response \[CR\] or partial response \[PR\]) or achieving stable disease for a minimum duration of 4 months, objective response rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST version \[v\] 1.…
Inclusion Criteria: * Must be ≥ 18 years of age * Ability to understand and the willingness to sign a written informed consent document. Patient must sign the informed consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Participants must have histologically confirmed advanced (International Federation of Gynecology and Obstetrics \[FIGO\] stage III or IV), persistent, or recurrent endometrial cancer (histologic documentation of recurrence not required) that has…
Undergo blood sample collection
Undergo CT scan
Given PO
Given PO
Undergo MRI
Undergo PET scan
Ancillary studies