Recruiting NCT06492616

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

Phase III Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Elacestrant, Anastrozole, Letrozole, Exemestane.
Who it may be relevant to: Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +23
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study

Overview

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.

Interventions

Drug Elacestrant
Administered as oral tablets
Drug Anastrozole
Administered as oral tablets
Drug Letrozole
Administered as oral tablets
Drug Exemestane
Administered as oral tablets
Drug Tamoxifen
Administered as oral tablets

Primary outcome measures

Invasive Breast Cancer-Free Survival (IBCFS) [Time frame: Up to 5 years]

Secondary outcome measures (10)

Distant Relapse-Free Survival (DRFS) [Time frame: Up to 5 years]
Overall Survival (OS) [Time frame: Up to 5 years]
Invasive Disease-Free Survival (IDFS) [Time frame: Up to 5 years]
Number of Participants With Adverse Events (AEs) [Time frame: Up to 5 years plus 28 days]
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) [Time frame: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5]
Change from Baseline in the Physical Functioning Sub-Scale Score as Assessed by EORTC QLQ-C30 [Time frame: 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) [Time frame: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5]
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) [Time frame: 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 [Time frame: Predose up to 4 hours postdose]
Maximum Plasma Concentration at Steady State (Cmaxss) of Elacestrant [Time frame: Predose up to 4 hours postdose]

Eligibility criteria

Inclusion criteria

Histopathologically or cytologically confirmed ER-positive (≥ 10% by immunohistochemistry \[IHC\]), HER2-negative \[IHC = 0, 1+, 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.

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 are off current adjuvant endocrine therapy more than 6 months prior to randomization

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment