Elacestrant for Breast Cancer

(ELEGANT Trial)

Recruiting at 49 trial locations

Overseen By Stemline Trials

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Stemline Therapeutics, Inc.

Must be taking: Endocrine therapy

Disqualifiers: Inflammatory breast cancer, prior malignancy, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.

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

The trial does not specify if you must stop taking your current medications. However, you must have completed or discontinued any prior CDK4/6 or PARP inhibitors before joining the trial.

What data supports the idea that Elacestrant for Breast Cancer is an effective drug?

The available research shows that Elacestrant, also known as Orserdu, has been approved by the USFDA for treating certain types of breast cancer. It is specifically used for advanced or metastatic breast cancer that is estrogen receptor-positive and HER2-negative. The drug has shown anticancer activity in both lab and animal studies. In a Phase III trial called EMERALD, Elacestrant was compared to standard endocrine therapy and demonstrated effectiveness in patients who had already received other treatments. This suggests that Elacestrant can be a beneficial option for patients with this type of breast cancer. ^{1 2 3 4 5}

What safety data is available for Elacestrant in breast cancer treatment?

Elacestrant, also known as Orserdu, was approved by the FDA in January 2023 for treating ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. The safety profile of Elacestrant has been discussed in clinical data from randomized trials, including the phase 3 EMERALD trial, which showed improved median progression-free survival. Treatment-related adverse reactions have been summarized, and drug interactions with CYP3A4 inhibitors and inducers have been noted. Dose reduction is recommended for patients with moderate hepatic dysfunction. Ongoing studies are evaluating its safety in severe hepatic dysfunction and among racial and ethnic minority groups. ^{1 2 6 7 8}

Is the drug Elacestrant a promising treatment for breast cancer?

Yes, Elacestrant is a promising drug for breast cancer. It has been approved by the FDA for treating certain types of advanced breast cancer. It works by targeting and breaking down estrogen receptors, which are often involved in the growth of breast cancer cells. Studies have shown that Elacestrant can effectively slow down or stop the growth of these cancer cells, making it a valuable option for patients. ^{1 2 3 7 9}

Research Team

Medical Director

Principal Investigator

Stemline Therapeutics, Inc.

Eligibility Criteria

This trial is for men and women with ER+, HER2- early breast cancer at high risk of recurrence. They must have completed 24 to 60 months of endocrine therapy, such as AIs or tamoxifen, possibly with a CDK4/6 inhibitor but not currently on it. Participants should not have any evidence of cancer recurrence or distant metastases.

Inclusion Criteria

Key

I was initially considered at high risk of my cancer coming back.

My breast cancer is ER-positive, HER2-negative, and has not spread or come back.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either elacestrant or standard endocrine therapy for 5 years

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Treatment Details

Interventions

• Elacestrant (Selective Estrogen Receptor Degrader)

Trial Overview The study compares the effectiveness of elacestrant against standard endocrine therapies like anastrozole, letrozole, exemestane, and tamoxifen in preventing breast cancer from coming back.

Participant Groups

Group I: Standard of Care (SoC) Endocrine Therapy Experimental Treatment 4 Interventions

Participants will receive the SoC endocrine therapy that was used prior to randomization: * AI (anastrozole 1 mg QD, letrozole 2.5 mg QD, or exemestane 25 mg QD); or * Tamoxifen 20 mg QD

Group II: Elacestrant Experimental Treatment 1 Intervention

Participants will receive 345 milligrams (mg) elacestrant once daily (QD) for 5 years

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+

Findings from Research

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]

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]

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]

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, 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]

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 (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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Elacestrant: First Approval. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Elacestrant: a new FDA-approved SERD for the treatment of breast cancer. [2023]

3. France pubmed.ncbi.nlm.nih.gov

Pharmacokinetic and Pharmacodynamic Studies of Elacestrant, A Novel Oral Selective Estrogen Receptor Degrader, in Healthy Post-Menopausal Women. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States 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. [2023]

6. United Arab Emirates pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Elacestrant for ER-Positive HER2-Negative Advanced Breast Cancer. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Pharmacology and pharmacokinetics of elacestrant. [2023]

9. United States 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. [2018]