What side effects are associated with this type of intervention?

Common treatments for breast cancer similar to Elacestrant, a Selective Estrogen Receptor Degrader (SERD), include other SERDs, aromatase inhibitors, and selective estrogen receptor modulators (SERMs). Known side effects of these treatments can include hot flashes, fatigue, joint pain, bone density loss, and an increased risk of cardiovascular issues. SERDs like Elacestrant may also cause gastrointestinal disturbances and liver function abnormalities. Aromatase inhibitors are particularly associated with bone density loss and fractures, while SERMs can increase the risk of thromboembolic events and uterine cancer.

What prior FDA approvals exist?

The FDA has approved several endocrine therapies for the treatment of breast cancer, particularly for hormone receptor-positive subtypes. Fulvestrant, a Selective Estrogen Receptor Degrader (SERD), is one such drug that has been approved for use in patients with advanced breast cancer. Other related drugs include aromatase inhibitors like letrozole and anastrozole, which reduce estrogen levels, and selective estrogen receptor modulators (SERMs) like tamoxifen, which block estrogen receptors. These therapies are often used in various combinations and sequences to manage hormone receptor-positive breast cancer.

What other types of research exist?

Promising novel alternatives to Elacestrant for breast cancer patients include: 1) Fulvestrant, another SERD, which is well-established and often used in combination with CDK4/6 inhibitors. 2) Newer SERDs like Giredestrant and Camizestrant, which are currently being evaluated in clinical trials. 3) CDK4/6 inhibitors such as Abemaciclib, Palbociclib, and Ribociclib, which are often used in combination with endocrine therapies. 4) PI3K inhibitors like Alpelisib for patients with PIK3CA mutations. 5) mTOR inhibitors such as Everolimus, which can be combined with endocrine therapy for enhanced efficacy.

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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)

Must not have

Prior treatment with elacestrant, GDC-0810, GDC-0927, GDC-9545, LSZ102, AZD9496, bazedoxifene, or other investigational SERD or investigational ER antagonist

Presence of symptomatic visceral disease as defined in protocol

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

Pivotal Trial

No Placebo-Only Group

Summary

This trial tests elacestrant, a new drug, in postmenopausal women and men with advanced ER+/HER2- breast cancer that has not responded to previous hormone therapies. Elacestrant aims to stop cancer growth by blocking the estrogen receptor. It has shown promise in patients with this type of breast cancer who have already tried other treatments.

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.

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.

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.

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®.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not been treated with specific experimental breast cancer drugs before.

Select...

My internal organs are affected by my condition.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival in All Subjects

Progression-free Survival in ESR1-mut Subjects

Secondary study objectives

Overall Survival in All Subjects

Overall Survival in ESR1-mut Subjects

Side effects data

From 2024 Phase 3 trial • 478 Patients • NCT03778931

35%

Nausea

19%

Fatigue

19%

Vomiting

15%

Decreased appetite

14%

Diarrhoea

14%

Arthralgia

14%

Back pain

13%

Aspartate aminotransferase increased

12%

Constipation

12%

Headache

11%

Hot flush

10%

Dyspepsia

Asthenia

Anaemia

Alanine aminotransferase increased

Insomnia

Dyspnoea

Pain in extremity

Urinary tract infection

Blood cholesterol increased

Blood alkaline phosphatase increased

Abdominal pain

Musculoskeletal chest pain

Cough

Bone pain

Myalgia

Musculoskeletal pain

Lymphocyte count decreased

Blood pressure Increased

Blood glucose increased

Spinal cord compression

Small intestinal obstruction

100%

80%

60%

40%

20%

Study treatment Arm

Elacestrant

Standard of Care (SoC)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2019

Completed Phase 3

~560

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer, particularly hormone receptor-positive types, include endocrine therapies and targeted agents. Selective Estrogen Receptor Modulators (SERMs) like tamoxifen block estrogen receptors on cancer cells, preventing estrogen from promoting cancer growth. Selective Estrogen Receptor Degraders (SERDs) such as fulvestrant and elacestrant not only block but also degrade estrogen receptors, reducing the number of receptors available. Aromatase inhibitors (AIs) like letrozole reduce estrogen production in postmenopausal women. Additionally, CDK4/6 inhibitors target proteins that regulate cell division, thereby slowing cancer progression. These mechanisms are vital for personalizing treatment, improving efficacy, and reducing adverse effects for breast cancer patients.