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Uterine SarcomaPhase 2NCT07467772

Ph 2 Elacestrant in ER Positive Uterine Sarcomas

A Phase 2 study testing Elacestrant in people with Uterine Sarcoma and Uterine Leiomyosarcoma, run by Dana-Farber Cancer Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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) Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Elacestrant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
25 Mar 2026to Apr 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 48Show fewer
  • 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.
  • Women of childbearing age, women who are made postmenopausal through use of GNRH agonists must agree to use adequate contraception for the duration of protocol treatment and for at least 6 months after the last dose of elacestrant if the risk of conception exists.
  • Adequate contraception is defined as one highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the participant and/or partner.
  • Highly Effective Non-Hormonal Contraception
  • Methods of birth control which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly are considered highly effective forms of contraception.
  • The following non-hormonal methods of contraception are acceptable:
  • True abstinence when this is in line with the preferred and usual lifestyle of the participant. [Periodic abstinence (e.g., calendar, ovulation, symptothermal post-ovulation methods) and withdrawal are not acceptable methods of contraception].
  • Male sterilization (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female participants, the vasectomized male partner should be the sole partner.
  • OR Effective Non-Hormonal Contraception
  • Alternatively, two of the following effective forms of contraception may be used instead:
  • Placement of non-hormonal intrauterine device (IUD) or intrauterine system (IUS). Consideration should be given to the type of device being15used, as there is higher failure rates quoted for certain types, e.g., steel or copper wire.
  • Condom with spermicidal foam/gel/film/cream/suppository.
  • Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
  • The use of barrier contraceptives should always be supplemented with the use of spermicide. Failure rates indicate that, when used alone, the diaphragm and condom are not highly effective forms of contraception. Therefore, the use of additional spermicides does confer additional theoretical contraceptive protection. However, spermicides alone are ineffective at preventing pregnancy when the whole ejaculate is spilled. Therefore, spermicides are not a barrier method of contraception and should not be used alone.
  • It should be noted that two forms of effective contraception are required. A double barrier method is acceptable, which is defined as condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
  • Premenopausal women must have a negative serum or urine pregnancy test. Pregnancy testing does not need to be pursued in female participants who are:
  • Age > 60 years; or
  • Age < 60 with intact uterus and amenorrhea for 12 consecutive months or more AND estrogen (estradiol) levels within postmenopausal range; or
  • Documented Status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation
  • Women must be postmenopausal, which is defined as any of the following:
  • Age ≥ 60 years
  • Age < 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and FSH, and estradiol in the postmenopausal range per local normal range
  • Premenopausal women must be on GnRH agonist prior to study entry are eligible. Women in this group MUST remain on the GnRH agonist for the duration of protocol treatment.
  • Status-post bilateral oophorectomy - After adequate healing post-surgery

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Suzanne George, MD contact

617-632-5204

suzanne_george@dfci.harvard.edu

United States1 site, 1 recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Suzanne George, MD, 877-338-7425

    Recruiting

Other trials in United States

About this study

Official title: A Phase 2 Study Evaluating the Efficacy of Elacestrant in Patients With Estrogen Receptor Positive Uterine Sarcomas

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)

Read the detailed description

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 Imaging (MRI) scans, or Positron Emission (PET) scans, and electrocardiograms (ECGs).

It is expected that about 30 people will take part in this research study. Stemline-Menarini is supporting this research study by providing the study drug.

Being tested
Elacestrant
Medical subject headings
Sarcoma, Endometrial Stromal, Perivascular Epithelioid Cell Neoplasms, Adenosarcoma of the uterus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElacestrantDrug

    Also called RAD1901, Elacestrant Hydrochloride, Elacestrant Dihydrochloride, ASYM-122762

    Selective estrogen receptor degrader, tablet taken orally per protocol.

Study groups in NCT07467772
Study groupRoleWhat they receive
ElacestrantExperimental30 participants will be enrolled and will complete the following: * Baseline visit * Cycle 1 through End of Treatment (28 day cycles) --Days 1 - 28: predetermined dose of Elacestrant 1x daily * End of treatment visit * 30 day post-treatment follow up * Long term follow every 3 months
Receives: Drug: Elacestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    ORR is defined as proportion of participants achieving partial response (PR) or better on treatment per the Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1 (Eisenhauer et al. Eur J Ca 2009; section 11.0).

    Measured: Observed on treatment plus 30 days; Disease assessed on treatment every 8 (+/- 3 days) weeks for the first 14 cycles, then every 12 (+/- 3 days) weeks thereafter with longest follow-up estimated as 12 months.

  2. Treatment-Related Grade 3-4 Adverse Event (AE) Rate

    Percentage of participants who experience an AE of grade 3 or 4 with treatment attribution of possible, probable or definite per Common Toxicity Adverse Event Criteria (CTCAE) version 5 on treatment.

    Measured: Assessed continuously on treatment plus 30 days with longest follow-up estimated as 13 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2026
  2. Study start25 Mar 2026
  3. Primary completionJul 2027 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07467772
Sponsor's protocol ID
25-822
Status last verified
May 2026
First submitted
12 Feb 2026
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Elacestrant in people with Uterine Sarcoma and Uterine Leiomyosarcoma, run by Dana-Farber Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 48 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Suzanne George, MD (617-632-5204, suzanne_george@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Observed on treatment plus 30 days; Disease assessed on treatment every 8 (+/- 3 days) weeks for the first 14 cycles, then every 12 (+/- 3 days) weeks thereafter with longest follow-up estimated as 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07467772.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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