Elacestrant for Breast Cancer

(ELCIN Trial)

Not currently recruiting at 41 trial locations

Overseen By Stemline Trials

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stemline Therapeutics, Inc.

Must be taking: LHRH agonists

Must not be taking: CDK4/6 inhibitors, Chemotherapy

Disqualifiers: CNS metastases, Visceral crisis, 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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the drug elacestrant to evaluate its effectiveness and safety for people with advanced breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor-2 negative (HER2-). The focus is on patients whose cancer has spread and who have not yet received certain targeted cancer medicines at this advanced stage. Participants will take a tablet form of elacestrant daily for up to six months. The trial seeks participants whose breast cancer has spread despite previous hormone treatments. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in breast cancer treatment.

Do I need to stop my current medications to join the trial?

The trial requires stopping certain medications before starting. You must stop any endocrine therapy at least 14 days before the first dose and avoid certain herbal preparations 7 days prior. If you're on fulvestrant, the last injection should be at least 42 days before starting the study drug.

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

Research has shown that elacestrant, a treatment for advanced breast cancer, has a safety profile similar to other hormone therapies, indicating it is generally well-tolerated by patients. Studies have used elacestrant alone and with other drugs, and it did not increase the risk of unwanted side effects. Previous patients used it with various targeted therapies, demonstrating good tolerability. This suggests that elacestrant may be a safe option for treating breast cancer in many patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Elacestrant is unique because it acts as a selective estrogen receptor degrader (SERD), which is different from traditional treatments like tamoxifen or aromatase inhibitors that mainly block estrogen. Researchers are excited about elacestrant because it directly targets and breaks down the estrogen receptor, which can be particularly effective in hormone-receptor-positive breast cancer. This approach may offer a powerful alternative for patients whose cancer continues to grow despite other hormonal therapies.

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

Research has shown that elacestrant, which participants in this trial will receive, may help treat hormone receptor-positive metastatic breast cancer. In the EMERALD study, patients with a specific mutation in their cancer lived for about 3.8 months before their condition worsened. Another study found that elacestrant helped patients live without their cancer worsening for about 5 to 7 months. Additionally, when combined with another drug called abemaciclib, elacestrant caused tumors to shrink or disappear in 18% of patients. These findings suggest that elacestrant could be effective for some patients with advanced breast cancer. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for men and women over 18 with ER+/HER2- advanced/metastatic breast cancer who haven't had CDK4/6 inhibitors before. Participants must have received up to two prior hormone therapies, have certain blood and organ function levels, possibly be on LHRH agonists if premenopausal or perimenopausal, and not be planning major surgery or other specific treatments.

Inclusion Criteria

Your absolute neutrophil count is 1.5 or more.

Your hemoglobin level is at least 9.0 grams per deciliter.

Your blood albumin level is at least 3.0 g/dL (or 30 g/L).

Exclusion Criteria

I haven't taken hormone therapy in the last 14 days.

I haven't taken any experimental cancer treatments recently.

My cancer has spread to my brain or spinal cord.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive elacestrant starting at 400 mg daily until disease progression or treatment discontinuation

Up to 6 months

Survival Follow-Up

Participants are followed for survival approximately every 3 months

24 months

Adverse Events Follow-Up

Participants are monitored for adverse events for 28 days after the last treatment administration

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Elacestrant

Trial Overview The study tests the effectiveness and safety of a drug called Elacestrant over six months in patients with a specific type of breast cancer that has spread. It aims to see how well this drug works when no previous CDK4/6 inhibitor therapy was given in the metastatic setting.

How Is the Trial Designed?

Group I: Elacestrant Experimental Treatment 1 Intervention

Subjects will take a starting dose of 400 mg of elacestrant dihydrochloride in tablet form once daily for up to 6 months.

Elacestrant is already approved in United States, European Union for the following indications:

Approved in United States as Orserdu for:

• ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

Approved in European Union as Orserdu for:

• ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

Who Is Running the Clinical Trial?

Stemline Therapeutics, Inc.

Lead Sponsor

Trials

24

Recruited

6,500+

Stemline Therapeutics, Inc.

Lead Sponsor

Trials

24

Recruited

6,500+

Published Research Related to This Trial

Elacestrant (ORSERDU™) is a newly approved oral medication for treating advanced or metastatic breast cancer in postmenopausal women and adult men with specific estrogen receptor mutations, following at least one line of endocrine therapy.

The drug specifically targets estrogen receptor-positive, HER2-negative breast cancer, and its approval in the USA marks a significant milestone in its development, with ongoing regulatory assessments in the EU.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elacestrant: First Approval. Hoy, SM.[2023]

Elacestrant (RAD-1901) is a selective estrogen receptor degrader that was approved by the USFDA for treating ER+ HER2-positive breast cancer, demonstrating anticancer activity in both laboratory and animal models.

The review discusses Elacestrant's development, including its medicinal chemistry, mechanism of action, and safety profile based on clinical trial data, highlighting its potential as an effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elacestrant: a new FDA-approved SERD for the treatment of breast cancer. Bhatia, N., Thareja, S.[2023]

Elacestrant, a selective estrogen receptor degrader, was found to be safe and well tolerated in a study involving 140 postmenopausal women, with doses up to 1000 mg daily not reaching the maximum tolerated dose.

The drug showed good oral bioavailability and a half-life of 27 to 47 hours, allowing for once-daily dosing, while effectively engaging estrogen receptors and demonstrating some ability to cross the blood-brain barrier.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic and Pharmacodynamic Studies of Elacestrant, A Novel Oral Selective Estrogen Receptor Degrader, in Healthy Post-Menopausal Women. Conlan, MG., de Vries, EFJ., Glaudemans, A., et al.[2021]

Elacestrant was approved by the FDA for treating advanced or metastatic breast cancer in postmenopausal women and adult men with specific estrogen receptor mutations, highlighting its targeted approach for patients who have not responded to prior endocrine therapy.

The summary includes important details about elacestrant's mechanism of action and safety profile, which are crucial for understanding its role in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Approval of Elacestrant as a Selective Estrogen Receptor Degrader for the Treatment of Metastatic Breast Cancer. De, SK.[2023]

Elacestrant is the first oral selective estrogen receptor degrader (SERD) approved by the FDA for treating ER/PR-positive, HER2-negative metastatic breast cancer with ESR1 mutations, showing improved median progression-free survival compared to standard endocrine therapy in the EMERALD trial.

The drug acts as a mixed ER agonist/antagonist and has specific metabolic considerations, being primarily processed by CYP3A4, which can lead to drug interactions; dose adjustments are recommended for patients with moderate hepatic dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacology and pharmacokinetics of elacestrant. Beumer, JH., Foldi, J.[2023]

Elacestrant, an oral selective estrogen receptor downregulator, was approved by the FDA in January 2023 for treating hormone receptor positive (HR+) HER2- advanced breast cancer, showing improved progression-free survival in patients with ESR1 mutations who had previously failed treatment with CDK 4/6 inhibitors and endocrine therapy.

Clinical trials indicate that elacestrant has a safety profile comparable to existing endocrine therapies and provides an effective alternative treatment option, especially for patients who have not responded to standard therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elacestrant for ER-Positive HER2-Negative Advanced Breast Cancer. Hageman, E., Lussier, ME.[2023]

The phase I trial assessed the safety and efficacy of elacestrant, a selective estrogen receptor degrader, specifically in patients with breast cancer.

This study represents an important step in evaluating new treatment options for breast cancer, focusing on a novel mechanism of action that targets estrogen receptors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Signs of Response to Elacestrant Seen in ER+ HER2- Breast Cancer. [2021]

Elacestrant (RAD1901) effectively degrades estrogen receptors and inhibits the growth of estrogen receptor-positive (ER+) breast cancer cells in both laboratory and patient-derived models, showing significant antitumor activity.

The combination of elacestrant with other therapies like palbociclib or everolimus enhances its efficacy, suggesting it could be a valuable treatment option for patients with ER+ breast cancer, including those with resistant mutations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elacestrant (RAD1901), a Selective Estrogen Receptor Degrader (SERD), Has Antitumor Activity in Multiple ER+ Breast Cancer Patient-derived Xenograft Models. Bihani, T., Patel, HK., Arlt, H., et al.[2018]

In a phase III trial involving 477 patients with ER-positive/HER2-negative advanced breast cancer, elacestrant significantly improved progression-free survival (PFS) compared to standard-of-care endocrine therapy, with a hazard ratio of 0.70 for all patients and 0.55 for those with ESR1 mutations.

While elacestrant showed promising efficacy, it was associated with a higher rate of treatment-related adverse events, including nausea, and a greater percentage of patients discontinuing treatment due to side effects compared to standard therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elacestrant (oral selective estrogen receptor degrader) Versus Standard Endocrine Therapy for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Results From the Randomized Phase III EMERALD Trial. Bidard, FC., Kaklamani, VG., Neven, P., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11847623/

Elacestrant in hormone receptor-positive metastatic breast ... Elacestrant shows promise for improving outcomes in hormone receptor-positive metastatic breast cancer, but further research is needed to confirm its ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.1071

Real-world (RW) elacestrant use patterns and therapeutic ... In the EMERALD study, pts with ESR1-mutant (ESR1m) HR+/HER2-negative aBC had a median progression free survival (PFS) of 3.8 months (mos). Here, ...

3. targetedonc.com targetedonc.com/view/real-world-data-reveal-longer-pfs-with-elacestrant-in-breast-cancer

Real-World Data Reveal Longer PFS With Elacestrant in ... Wander acknowledges the lack of uniform scans, but despite these limitations, elacestrant performed well, with PFS estimates of 5 to 7 months.

4. orserduhcp.com orserduhcp.com/efficacy/

EMERALD Trial Primary Endpoint & Efficacy - orserdu ORSERDU (elacestrant) is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor ...

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11895172/

Post-marketing safety of elacestrant in breast cancer These data indicate that the safety profile of elacestrant in clinical trials is similar to that of other endocrine therapy drugs but with a ...

7. 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.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12215442/

Evaluation of Safety of Elacestrant in Patients with Breast ... This study aims to evaluate the safety profile of elacestrant in real-world settings using data from the FDA adverse event (AE) reporting system (FAERS) ...

9. orserduhcp.com orserduhcp.com/emerald-trial/

EMERALD Trial for ESR1-Mutations | ORSERDU® (elacestrant) Review data from the EMERALD trial, the only pivotal trial in ESR1-mutated, ER+/HER2- mBC patients with 100% prior ET + CDK4/6i exposure.

10. onclive.com onclive.com/view/elacestrant-shows-tolerability-in-combination-with-cdk4-6-pi3k-inhibitors-in-advanced-er-breast-cancer

Elacestrant Shows Tolerability in Combination With CDK4/ ... Elacestrant demonstrated tolerability with multiple targeted agents in ER-positive, HER2-negative advanced breast cancer, showing potential as ...