A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence

Phase 3

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: Elacestrant; Drug: Anastrozole; Drug: Letrozole; Drug: Exemestane; Drug: Tamoxifen

• Registration Number: NCT06492616
• Lead Sponsor: Stemline Therapeutics, Inc.

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-01
• Study First Posted: 2024-07-09
• Study Start: 2024-09-27
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Primary Completion: 2029-08
• Study Completion: 2032-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4220

Inclusion Criteria

• 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 considered at high risk of recurrence at initial staging
• 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)
• Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor must have already completed or discontinued these treatments.

Key

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Exclusion Criteria

• Participants with inflammatory breast cancer
• History of any prior (ipsilateral and/or contralateral) invasive breast cancer
• Participant with history of malignancy within 3 years of the date of randomization, except for adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix
• Participants who have had more than a 6-month continuous interruption of prior SoC adjuvant endocrine therapy or who discontinued adjuvant endocrine therapy more than 6 months prior to randomization

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care (SoC) Endocrine Therapy	Letrozole	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
Elacestrant	Elacestrant	Participants will receive 345 milligrams (mg) elacestrant once daily (QD) for 5 years
Standard of Care (SoC) Endocrine Therapy	Anastrozole	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
Standard of Care (SoC) Endocrine Therapy	Exemestane	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
Standard of Care (SoC) Endocrine Therapy	Tamoxifen	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

Primary Outcome Measures

Name	Time	Method
Invasive Breast Cancer-Free Survival (IBCFS)	Up to 5 years	Assessed by the time from date of randomization to the date of first occurrence of: * Ipsilateral invasive breast tumor recurrence; * Local/regional invasive breast cancer recurrence; * Distant recurrence; * Contralateral invasive breast cancer, or; * Death attributable to any cause

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	Up to 5 years plus 28 days
Maximum Plasma Concentration at Steady State (Cmaxss) of Elacestrant	Predose up to 4 hours postdose
Overall Survival (OS)	Up to 5 years
Change from Baseline in Global Health Status Quality of Life Scale score, as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)	Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
Distant Relapse-Free Survival (DRFS)	Up to 5 years	Assessed by the time from date of randomization to the date of first occurrence of: * Distant recurrence, or; * Death attributable to any cause
Invasive Disease-Free Survival (IDFS)	Up to 5 years	Assessed by the time from date of randomization to the date of first occurrence of: * Local/regional recurrence; * Contralateral recurrence; * Second primary non-breast invasive cancer; * Distant recurrence, or; * Death attributable to any cause
Change from Baseline in the Physical Functioning Sub-Scale Score as Assessed by EORTC QLQ-C30	Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
Change From Baseline in the Breast Cancer Endocrine Therapy Symptoms Sub-Scale Score, as Assessed by the EORTC Quality of Life Breast Cancer Questionnaire module (EORTC QLQ-BR42)	Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
Area Under the Plasma Concentration Versus Time Curve at Steady State (AUCss) of Elacestrant	Predose up to 4 hours postdose
Change From Baseline in Side Effects, as Assessed by the Question 168 of the European Organization for the Research and Treatment of Cancer Question Library (EORTC Q168)	Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5

Trial Locations

Locations (4)

Cancer Centers of Kansas; 🇺🇸 Wichita, Kansas, United States

Miami Valley Hospital South; 🇺🇸 Centerville, Ohio, United States

Virginia Cancer Institute; 🇺🇸 Mechanicsville, Virginia, United States

Mercy Medical Center; 🇺🇸 Baltimore, Maryland, United States