Elacestrant + Abemaciclib for Endometrial Cancer

Recruiting at 6 trial locations

Overseen By Angela Green, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: LHRH agonist

Must not be taking: mTOR inhibitors, CDK4/6 inhibitors

Disqualifiers: Visceral crisis, ILD, Hyperlipidemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of two drugs, elacestrant and abemaciclib, in treating advanced or recurrent estrogen receptor-positive (ER+) endometrial cancer, which grows in response to estrogen. Researchers aim to determine whether using these drugs together or elacestrant alone is both safe and effective. Patients previously treated with chemotherapy and a PD-1 inhibitor, but not a CDK4/6 inhibitor, may be suitable for this study. As a Phase 2 trial, this research focuses on assessing 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 a 14-day period without chemotherapy or radiotherapy before starting. You should also avoid certain medications and herbal supplements that affect liver enzymes. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using elacestrant and abemaciclib together is generally safe. These drugs maintain similar safety levels when combined as when used separately, indicating no added risk of side effects. Common side effects of elacestrant alone include nausea, tiredness, and diarrhea, but these are usually mild.

Abemaciclib has already received approval for other uses, supporting its safety profile. Although the combination is still under study for endometrial cancer, past results in similar conditions are encouraging. Prospective participants should discuss any possible side effects and risks with the trial team before joining. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for endometrial cancer because they target the cancer in new ways. Unlike current treatments like hormonal therapies and chemotherapy, Abemaciclib and Elacestrant work by uniquely targeting hormone receptors and the cell cycle. Abemaciclib is a CDK4/6 inhibitor that disrupts the cancer cell cycle, while Elacestrant is a selective estrogen receptor degrader (SERD) that reduces the influence of estrogen on cancer growth. This combination could potentially offer a more effective treatment option by attacking the cancer cells from different angles, possibly improving outcomes for patients who have limited options with traditional therapies.

What evidence suggests that this trial's treatments could be effective for endometrial cancer?

This trial will compare the combination of elacestrant and abemaciclib with elacestrant alone for treating advanced or recurring ER+ endometrial cancer. Research has shown that using elacestrant and abemaciclib together yields promising results for advanced hormone receptor-positive cancers. In past studies with breast cancer patients, this combination prevented cancer progression for an average of 8.7 months. Specifically, patients' cancer did not progress for about 8.7 months on average. Elacestrant alone has also been effective, delaying cancer progression for about 5 to 7 months in similar cancer types. These findings suggest that these treatments might help manage advanced or recurring ER+ endometrial cancer by slowing its growth. ^{1 5 6 7 8}

Who Is on the Research Team?

Angela Green, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with advanced or recurrent ER+ endometrial cancer who've had platinum-based chemo and a PD-1 inhibitor, possibly one line of endocrine therapy but no CDK4/6 inhibitors. They must have an ECOG status of 0 or 1, agree to contraception if applicable, have certain lab values and tumor characteristics (ER-positive, p53 wt), measurable disease per RECIST v1.1 criteria, and not be pregnant or nursing.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

I am 18 years old or older.

I've had platinum-based chemotherapy and PD-1 inhibitor treatment before.

Exclusion Criteria

Known intolerance to either study drug or any of the excipients

I cannot take pills by mouth or have a condition that affects how my body absorbs food.

Patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to randomization, or is currently enrolled in any other type of medical research not scientifically or medically compatible with this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive elacestrant alone or in combination with abemaciclib for advanced or recurrent ER+ endometrial cancer

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Abemaciclib
• Elacestrant

Trial Overview

The study tests the effectiveness and safety of elacestrant alone or combined with abemaciclib in treating ER+ endometrial cancer that's advanced or come back after treatment. It aims to see how well these drugs work for patients who've already tried some other treatments.

How Is the Trial Designed?

Group I: Elacestrant alone Experimental Treatment 1 Intervention

Patients receiving elacestrant only should take orally once daily in the morning.

Group II: Abemaciclib plus Elacestrant Experimental Treatment 2 Interventions

Patients receiving both drugs should take elacestrant orally once daily with abemaciclib orally in the morning and abemaciclib orally only in the evening at the same time every day.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07209449

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 ...

2.

cancernetwork.com

cancernetwork.com/view/87-elacestrant-plus-abemaciclib-combination-in-patients-with-estrogen-receptor-positive-her2-negative-advanced-or-metastatic-breast-cancer

87 Elacestrant Plus Abemaciclib Combination in Patients ...

Elacestrant plus abemaciclib showed clinically important efficacy regardless of ESR1-mutation status.

3.

pharmacytimes.com

pharmacytimes.com/view/sabcs-2024-combination-of-elacestrant-and-abemaciclib-shows-promising-progression-free-survival-in-er-her2--advanced-breast-cancer

SABCS 2024: Combination of Elacestrant and ...

The combination of elacestrant and abemaciclib showed promising 8.7-month progression-free survival in ER+, HER2- advanced breast cancer, including in patients ...

4.

ajmc.com

ajmc.com/view/elacestrant-shows-real-world-effectiveness-in-metastatic-breast-cancers

Elacestrant Shows Real-World Effectiveness in Metastatic ...

Comparable safety and efficacy were evident in the complete response (5%), partial response (13%), stable disease (66%), and progressive ...

5.

patlynk.com

patlynk.com/trial/NCT07209449

Elacestrant and Abemaciclib for ER+ Endometrial Cancer

The study does not specify primary outcomes, but it will likely look at factors such as tumor response to treatment and the overall safety of the drugs.

6.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.1079

Elacestrant combinations in patients (pts) with ER+/HER2- ...

Elacestrant combinations continue to demonstrate safety consistent with the known profiles of each drug + SOC ET without increased risk of associated AEs.

7.

onclive.com

onclive.com/view/elacestrant-plus-abemaciclib-shows-efficacy-in-er-her2-advanced-or-metastatic-breast-cancer

Elacestrant Plus Abemaciclib Shows Efficacy in ER+/HER2

Elacestrant and abemaciclib combination showed an 18% objective response rate and 84% clinical benefit rate in ER-positive/HER2-negative breast ...

8.

asco.org

asco.org/abstracts-presentations/ABSTRACT459260

Elacestrant in combination with abemaciclib in patients (pts ...

Preliminary efficacy data showed encouraging antitumor activity. Elacestrant has the potential to become the ET backbone for combination regimens. 1.