Actively Recruiting
A Phase 2 Study Evaluating the Efficacy of Elacestrant in Patients With Estrogen Receptor Positive Uterine Sarcomas
Led by Dana-Farber Cancer Institute · Updated on 2026-05-22
30
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
S
Stemline Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Ph 2 Elacestrant in ER Positive Uterine Sarcomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed uterine sarcoma subtype: uterine leiomyosarcoma, endometrial stromal sarcoma, uterine adenosarcoma, or uterine PEComa
- Tumor shows moderate to strong estrogen receptor expression in 75% or more of tumor cells
- Locally advanced or metastatic disease not suitable for surgery
- Measurable disease with at least one lesion meeting size requirements
- Age 18 years or older at consent
- ECOG performance status 0 to 2
- Adequate organ and marrow function as defined
- HIV-positive participants on effective non-CYP3A4 interacting therapy with undetectable viral load within 6 months
- HBV viral load undetectable on suppressive therapy if indicated
- Treated and cured HCV infection or undetectable viral load if on treatment
- Treated brain metastases without disease progression
- Disease-free of prior invasive cancers for more than 5 years except certain skin or cervical carcinomas
- Completed prior chemotherapy or radiotherapy at least 2 weeks before study entry (6 weeks for certain drugs)
- Recovered from prior treatment side effects except alopecia
- Cardiac function class 2B or better per NYHA classification
- QTc interval below 450 msec
- Willing to comply with study protocol including treatment and visits
- Able to swallow and maintain pills
- Able and willing to sign informed consent or have authorized representative
- Women of childbearing potential must use adequate non-hormonal contraception during and 6 months after treatment
- Women must be postmenopausal or use GnRH agonists as specified
You will not qualify if you...
- Receiving other investigational agents
- History of allergic reactions to compounds similar to elacestrant
- Rapidly progressing symptomatic visceral disease with risk of life-threatening complications
- Uncontrolled intercurrent illness including active infection, uncontrolled diabetes, cardiac disease, or hypertension
- Psychiatric illness or social situations limiting compliance
- Treatment with strong CYP3A inducers/inhibitors within 2 weeks before study treatment
- Pregnant or nursing females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive Elacestrant tablets once daily in 28-day cycles to block estrogen receptors and slow cancer growth.
Baseline visit and regular visits every 8 weeks for the first 14 cycles, then every 12 weeks thereafter
Duration - 30 days post-treatment plus long-term follow-up every 3 months
Participants are monitored for safety and disease status after treatment ends, including a 30-day post-treatment visit and long-term follow-up every 3 months.
1 post-treatment visit and follow-up visits every 3 months
Trial Site Locations
Total: 1 location
1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
S
Suzanne George, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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