30 Participants NeededMy employer runs this trial

Elacestrant for Uterine Cancer

SG
Overseen BySuzanne George, MD
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: Dana-Farber Cancer Institute
Must be taking: GnRH agonists
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called elacestrant, a type of hormone therapy, for individuals with advanced uterine sarcomas that are estrogen receptor (ER)-positive. The trial aims to assess the treatment's effectiveness and safety. Participants take a daily dose and attend regular check-ins over several months. Ideal candidates have uterine sarcoma that cannot be surgically removed, is spreading, and shows strong signs of estrogen receptors in their tumors. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking strong CYP3A inducers or inhibitors at least 2 weeks before starting the study treatment. If you are on such medications, you will need to discuss alternatives with your doctor.

Is there any evidence suggesting that elacestrant is likely to be safe for humans?

Research has shown that elacestrant is generally safe for people. Previous studies report mild side effects, such as nausea, as the most common. This treatment is a pill that targets estrogen receptors in cancer cells to inhibit their growth.

In a study on breast cancer, elacestrant was noted for its ease of use and manageable side effects compared to other treatments. The FDA has already approved it for certain types of estrogen receptor-positive cancers, indicating its safety.

While research continues, current evidence supports elacestrant as a safe option for people with hormone-driven cancers.12345

Why do researchers think this study treatment might be promising for uterine cancer?

Elacestrant is unique because it offers a novel approach to treating uterine cancer by acting as an oral selective estrogen receptor degrader (SERD). Unlike traditional treatments that often involve surgery, chemotherapy, or hormonal therapies like tamoxifen, Elacestrant directly targets and degrades the estrogen receptor, which is crucial for the growth of certain uterine cancers. Researchers are excited about Elacestrant because its oral administration and specific mechanism could offer a more convenient and targeted treatment option with potentially fewer side effects.

What evidence suggests that elacestrant might be an effective treatment for uterine cancer?

Research has shown that elacestrant, a drug targeting estrogen receptors, may effectively treat certain estrogen-driven cancers. In the EMERALD trial, elacestrant reduced the risk of cancer progression or death by 45% compared to standard treatments. After six months, 34.3% of patients on elacestrant experienced no cancer progression, while only 20.4% of those on standard care did. Although most research focuses on breast cancer, similar benefits are anticipated for uterine sarcomas due to shared hormone receptors. Elacestrant blocks and breaks down estrogen receptors, crucial for the growth of these cancers. Participants in this trial will receive a predetermined daily dose of elacestrant to assess its effectiveness in treating uterine cancer.36789

Who Is on the Research Team?

SG

Suzanne George, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults (18+) with advanced or spreading uterine sarcomas that are estrogen receptor positive. Participants must have at least one tumor that can be measured, good general health, and adequate blood counts and organ function.

Inclusion Criteria

My cancer is advanced or has spread and cannot be treated with surgery.
I have at least one tumor that can be measured by scans or exam.
I am 18 years old or older.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive a predetermined dose of Elacestrant 1x daily in 28-day cycles

Up to 12 months
In-clinic visits every 8 weeks for the first 14 cycles, then every 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days post-treatment
1 visit (in-person)

Long-term follow-up

Participants are monitored every 3 months for long-term safety and effectiveness

Up to 13 months
Visits every 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Elacestrant

Trial Overview

The study tests elacestrant, a drug that blocks estrogen signals in cancer cells, to see if it works and is safe for people with ER-positive uterine sarcomas. All participants receive this medication.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ElacestrantExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials
1,128
Recruited
382,000+

Stemline Therapeutics, Inc.

Industry Sponsor

Trials
24
Recruited
6,500+

Citations

A Phase 2 Study Evaluating the Efficacy of Elacestrant in ...

This study is to evaluate the efficacy and safety of elacestrant, in participants with advanced estrogen receptor (ER)-positive uterine sarcomas.

NCT07209449 | A Study of Elacestrant Alone or in ...

The researchers are doing this study to find out whether elacestrant is an effective and safe treatment alone or in combination with abemaciclib for people with ...

Real-World Outcomes of Elacestrant in ER+, HER2−, ESR1 ...

In the EMERALD trial, single-agent elacestrant was associated with a significant 45% reduction in the risk of progression or death versus SOC ET in patients ...

A Phase 2 Study Evaluating the Efficacy of Elacestrant in ...

This study is to evaluate the efficacy and safety of elacestrant, in participants with advanced estrogen receptor (ER)-positive uterine ...

A Phase 2 Study of Elacestrant Alone or With Abemaciclib ...

Elacestrant blocks and breaks down ER, which plays a role in the growth and development of certain cancers. Abemaciclib blocks proteins called CDKs, which ...

Ph 2 Elacestrant in ER Positive Uterine Sarcomas

This study is to evaluate the efficacy and safety of elacestrant, in participants with advanced estrogen receptor (ER)-positive uterine sarcomas.

Evaluating Elacestrant in the Management of ER-Positive ...

In a Phase III clinical trial, elacestrant demonstrated a significant although modest improvement in median progression-free survival (PFS) ...

Updated Data Back Elacestrant as Potential Backbone for ...

In patients assigned elacestrant plus abemaciclib, the median PFS was 14.3 months (95% CI, 7.3–16.6 months), with a consistent benefit across ...

Elacestrant Elicits Positive Outcomes in Patients with ...

Among all patients, the 6-month PFS rates were 34.3% with elacestrant and 20.4% with SOC. The 12-month PFS rates were 22.32% and 9.42%, respectively. In ...