Elacestrant for Breast Cancer

(ELCIN Trial)

Recruiting at 35 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

61 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Elacestrant for breast cancer?

Elacestrant, also known as Orserdu, has been approved by the FDA for treating certain types of advanced breast cancer, showing effectiveness in clinical trials for patients with estrogen receptor-positive, HER2-negative breast cancer. It has demonstrated anticancer activity in both laboratory and human studies, particularly for those who have not responded to other endocrine therapies. ^{1 2 3 4 5}

Is Elacestrant safe for humans?

Elacestrant has been approved by the FDA for treating certain types of breast cancer, and its safety profile has been discussed in clinical trials. It may interact with other drugs and requires dose adjustments for people with liver issues, but ongoing studies are further evaluating its safety in different populations. ^{4 5 6 7 8}

How is the drug Elacestrant unique for treating breast cancer?

Elacestrant is unique because it is an oral selective estrogen receptor degrader (SERD) that targets and degrades estrogen receptors, which are often involved in the growth of certain breast cancers. It is specifically approved for advanced or metastatic breast cancer in patients with certain mutations, offering a new option for those who have progressed after other endocrine therapies. ^{3 4 5 8 9}

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy and safety of elacestrant over the course of 6 months in patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor-2 negative (HER2-) advanced/metastatic breast cancer who received no prior cyclin-dependent kinase targeting enzymes CDK4 and CDK6 inhibitor (CDK4/6i) in the metastatic setting.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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, 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 (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 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 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 (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. United States pubmed.ncbi.nlm.nih.gov

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

2. 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]

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

Elacestrant: First Approval. [2023]

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

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

6. Germany pubmed.ncbi.nlm.nih.gov

Pharmacology and pharmacokinetics of elacestrant. [2023]

7. 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]

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

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