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Selective Estrogen Receptor Degrader

Elacestrant for Breast Cancer (ELEGANT Trial)

Baltimore, MD

Phase 3

Recruiting

Research Sponsored by Stemline Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

* Histopathologically or cytologically confirmed ER-positive (≥ 10% by immunohistochemistry \[IHC\]), HER2-negative \[IHC = 0 or 1, or (IHC = 2 and in situ hybridization \[ISH\]-negative)\] on tumor biopsy or final surgical pathology specimen early stage resected invasive breast cancer without evidence of recurrence or distant metastases, per local laboratory, according to the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines

* Participants who have received at least 24 months but not more than 60 months of endocrine therapy (AIs or tamoxifen) with or without a CDK 4 and CKD 6 inhibitor (CDK4/6i)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

"This trial aims to compare a new drug called elacestrant with the usual hormone therapy for early breast cancer patients with a high risk of cancer coming back. The study will see which treatment is more

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Who is the study for?

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.Check my eligibility

What is being tested?

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

What are the potential side effects?

Potential side effects may include hot flashes, joint pain, nausea, fatigue associated with standard endocrine therapies; specific side effects related to elacestrant are under investigation.

Eligibility Criteria

Inclusion Criteria

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

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

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I have been on hormone therapy for 2-5 years, possibly with a CDK4/6 inhibitor.

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I have completed or stopped any treatments with CDK4/6 or PARP inhibitors.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Invasive Breast Cancer-Free Survival (IBCFS)

Secondary study objectives

Distant Relapse-Free Survival (DRFS)

Invasive Disease-Free Survival (IDFS)

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard of Care (SoC) Endocrine TherapyExperimental Treatment4 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: ElacestrantExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Elacestrant

2019

Completed Phase 3

~560

Anastrozole

2016