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Selective Estrogen Receptor Degrader (SERD)

Elacestrant for Advanced Breast Cancer (EMERALD Trial)

Phase 3

Waitlist Available

Research Sponsored by Radius Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must have ctDNA ESR1-mut or ESR1-WT status as determined by central testing with Guardant360CDx® before subject is randomized

Subjects must have received prior treatment with a CDK4/6 inhibitor in combination with either fulvestrant or an aromatase inhibitor (AI)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization until death due to any cause (estimated up to 24 months)

Awards & highlights

EMERALD Trial Summary

This trial is testing a new drug, elacestrant, to see if it is more effective and has fewer side effects than the current best treatments for advanced breast cancer (fulvestrant or aromatase inhibitors).

Who is the study for?

This trial is for adults with ER+/HER2- advanced breast cancer who have progressed after endocrine therapy, including a CDK4/6 inhibitor. Participants can be postmenopausal women or men willing to prevent pregnancy. They should have measurable disease and may have had one chemotherapy line in the metastatic setting but no prior treatment with certain investigational drugs.Check my eligibility

What is being tested?

The study tests elacestrant against standard treatments (fulvestrant or an aromatase inhibitor) in patients whose cancer has worsened on endocrine therapy. It's a Phase 3 trial, meaning it's later in the testing process and involves more participants to confirm effectiveness and monitor side effects.See study design

What are the potential side effects?

While specific side effects of elacestrant are not listed here, common ones for this type of drug include hot flashes, joint pain, fatigue, nausea, and increased risk of bone thinning or fractures. Side effects vary by individual.

EMERALD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer's ESR1 status was tested using Guardant360CDx®.

Select...

I have been treated with a CDK4/6 inhibitor and either fulvestrant or an AI.

Select...

My cancer can be measured by tests or is only in my bones.

Select...

My cancer is ER positive and HER2 negative.

Select...

I have advanced or metastatic breast cancer that cannot be removed or cured with surgery or radiation.

Select...

I have had 1-2 endocrine treatments for advanced breast cancer.

EMERALD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization until death due to any cause (estimated up to 24 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomization until death due to any cause (estimated up to 24 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until death due to any cause (estimated up to 24 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free Survival in All Subjects

Progression-free Survival in ESR1-mut Subjects

Secondary outcome measures

Overall Survival in All Subjects

Overall Survival in ESR1-mut Subjects

EMERALD Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ElacestrantExperimental Treatment1 Intervention

Subjects in Arm 1 will receive elacestrant

Group II: Standard of Care (SoC)Active Control1 Intervention

Subjects in Arm 2 will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Elacestrant

2015

Completed Phase 1

~80

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Radius Pharmaceuticals, Inc.Lead Sponsor

12 Previous Clinical Trials

378 Total Patients Enrolled

Stemline Therapeutics, Inc.Lead Sponsor

18 Previous Clinical Trials

1,407 Total Patients Enrolled

1 Trials studying Breast Cancer

400 Patients Enrolled for Breast Cancer

Sr. Director, Clinical OperationsStudy DirectorRadius Health, Inc.

4 Previous Clinical Trials

328 Total Patients Enrolled

Media Library

Elacestrant (Selective Estrogen Receptor Degrader (SERD)) Clinical Trial Eligibility Overview. Trial Name: NCT03778931 — Phase 3

Breast Cancer Research Study Groups: Elacestrant, Standard of Care (SoC)

Breast Cancer Clinical Trial 2023: Elacestrant Highlights & Side Effects. Trial Name: NCT03778931 — Phase 3

Elacestrant (Selective Estrogen Receptor Degrader (SERD)) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03778931 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Elacestrant received government sanctioning for therapeutic use?

"Elacestrant is in Phase 3 of clinical trials, meaning that while there is evidence of efficacy, multiple rounds of testing are needed to confirm its safety."

Answered by AI

What is the target enrollment number for this clinical trial?

"This study has already completed recruitment and is no longer looking for participants. The trial was posted on May 10th, 2019 and last updated on July 19th, 2022. However, there are 2695 trials actively recruiting breast cancer patients and 298 Elacestrant clinical trials currently enrolling patients."

Answered by AI

What type of cancer does Elacestrant usually target?

"Elacestrant is a possible treatment for patients that have progressed in their disease even after 2-3 years of tamoxifen therapy."

Answered by AI

Are subjects still needed for this experiment?

"This study is no longer recruiting patients. According to the posted information, the trial was first announced on May 10th, 2019 and was most recently updated on July 19th, 2022. If you are looking for other trials, 2695 studies involving breast cancer and 298 exploring Elacestrant are actively recruiting participants."

Answered by AI

What does the research say about Elacestrant's effectiveness?

"Elacestrant was first researched in 1995 at the National Institutes of Health Clinical Center. Since then, there have been a total of 630 clinical trials completed with 298 active trials. A large number of these studies are being conducted out of Austin, Texas."

Answered by AI

Is this clinical trial running in many places throughout North America?

"This study is open for enrolment at 58 different sites, some of which are in Austin, Cleveland and Glendale. To help manage participant burden, it is advised to choose a clinical site that is close to your residence."

Answered by AI

Recent research and studies

Future OncologyJournal

EMERALD: Phase III Trial of Elacestrant (RAD1901) Vs Endocrine Therapy for Previously Treated ER+ Advanced Breast Cancer

Bardia, Aditya, Philippe Aftimos, Teeru Bihani, Alfred T Anderson-Villaluz, JungAh Jung, Maureen G Conlan, and Virginia G Kaklamani. 2019. “EMERALD: Phase III Trial of Elacestrant (RAD1901) Vs Endocrine Therapy for Previously Treated ER+ Advanced Breast Cancer”. Future Oncology. Future Medicine Ltd. doi:10.2217/fon-2019-0370.

clinicaltrials.govStudy

Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer

2019. "Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03778931.