Phase 2 Study of Elacestrant Treatment in Women With Advanced Estrogen Receptor Positive Uterine Sarcomas

What this Trial Is About

This trial investigates the safety and effectiveness of elacestrant, a selective estrogen receptor degrader, in adults with advanced estrogen receptor-positive uterine sarcomas. The study focuses on specific subtypes including uterine leiomyosarcoma, endometrial stromal sarcoma, uterine adenosarcoma, and uterine PEComa. This phase 2, single-arm, open-label trial aims to evaluate how elacestrant may affect tumors that depend on estrogen for growth. The FDA has not approved elacestrant for this use yet. Participants will receive elacestrant orally once daily in 28-day treatment cycles, starting with a baseline visit followed by treatment cycles until the end of therapy. After completing treatment, there will be an end-of-treatment visit, a 30-day follow-up, and long-term monitoring every three months. The study is supported by Stemline-Menarini, which provides the study drug. Throughout the study, participants will undergo various assessments including blood and urine tests, CT, MRI, or PET scans, and electrocardiograms ECGs. Disease status will be monitored regularly during treatment and after, with response evaluated every 8 weeks initially, then every 12 weeks. Safety will be continuously assessed during treatment and up to 30 days after. The study expects about 30 participants and includes follow-up visits extending up to 12 months or more.

Ph 2 Elacestrant in ER Positive Uterine Sarcomas