Ph 2 Elacestrant in ER Positive Uterine Sarcomas

Recruiting now · Phase 2

Conditions studied: Uterine Sarcoma, Uterine Leiomyosarcoma, Endometrial Stromal Sarcoma, ESS, Perivascular Epithelioid Cell Tumors, Uterine Adenosarcoma, Uterine PEComa, Estrogen Receptor Positive Tumor, uLMS

In brief

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)

Key facts

Study ID: NCT07467772
Run by: Dana-Farber Cancer Institute
People needed: 30
Starts: 2026-03-25
Expected to finish: 2028-04-01
Last updated by the study team: 2026-05-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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 least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. See Section 12 (Measurement of Effect) for the evaluation of measurable disease.
Age ≥18 years at the time of consent
ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
Participants must have adequate organ and marrow function as defined below:
Hemoglobin ≥ 8.0 g/dL
absolute neutrophil count ≥1,000/mcL
platelets ≥100,000/mcL
total bilirubin ≤1.5 × institutional upper limit of normal (ULN)
AST(SGOT)/ALT(SGPT) ≤3.0 × institutional ULN (unless liver metastases are present in which case it must be ≤ 5 × ULN)
glomerular filtration rate (GFR) ≥60 mL/min/1.73 m2
Human immunodeficiency virus (HIV)-infected participants on effective non-CYP3A4 interacting (see Section 3.2.3) anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
Participants must be disease-free of prior invasive malignancies for > 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. NOTE: If there is a history of prior malignancy, participants must not be receiving other specific treatment for that cancer.
Participants should have completed prior treatment for their cancer: chemotherapy or radiotherapy must have been completed for greater than 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
Participants should have recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia.
Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.
Participants must have a QTc interval length of below 450 msec. QTc will be calculated via the Fridericia's formula.
Participant must be willing to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Participant must be able to swallow and maintain pills.
Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) and/or family member available will also be eligible.

You may not qualify if…

Participants who are receiving any other investigational agents.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to elacestrant.
Rapidly progressive, symptomatic, visceral spread of disease placing participant at risk of
life- threatening complications in the short term.
Participants with uncontrolled intercurrent illness, including but not limited to active infection, uncontrolled diabetes, cardiac disease, hypertension or conditions that in the opinion of the investigator would compromise participant safety or study participation
Participants with psychiatric illness/social situations that would limit compliance with study requirements.
Treatment with strong CYP3A inducers/inhibitors within 2 weeks before first study treatment administration or five elimination half-lives, whichever is longest and cannot be replaced. See Appendix B for a list of medications that are CYP3A inducers/inhibitors.
Female participants who are pregnant or nursing.

Where it is running

Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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