Dana-Farber Cancer Institute
This study is to evaluate the efficacy and safety of elacestrant, in participants with advanced estrogen receptor (ER)-positive uterine sarcomas. The name of the study drug involved in this research study is: -Elacestrant (a type of selective estrogen receptor degrader)
This is a single-arm, open-label, phase 2 study evaluating the efficacy and safety of elacestrant in participants with advanced estrogen receptor (ER)-positive uterine sarcomas. Elacestrant is designed to block estrogen receptors, which may slow down or stop the growth of cancers that rely on estrogen to grow. The U.S. Food and Drug Administration (FDA) has not approved elacestrant as a treatment for ER positive uterine sarcoma. The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, Computerized Tomography (CT) scans, Magnetic Resonance I…
Inclusion Criteria: Participant must have histologically confirmed uterine sarcoma of one of the following subtypes: uterine leiomyosarcoma (uLMS), endometrial stromal sarcoma (ESS), uterine adenosarcoma, or uterine PEComa. Tumor must have moderate to strong immunohistochemical expression in ≥75% of tumor cells of estrogen receptor (ER) as assessed by institutional pathology review. Participants must have locally advanced or metastatic disease that is not amenable to surgery. Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at lea…
Selective estrogen receptor degrader, tablet taken orally per protocol.
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