NCT06492616ClinicalTrials.gov

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

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

RecruitingTaking participants now, according to the registry record.

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In brief

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.

Phase 34,220 participants sought567 sites28 countries

Registered in 1 registry

ClinicalTrials.govNCT06492616Open this record at ClinicalTrials.govSynced 5 days ago

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Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2024-07-09; recorded start 2024-09-27
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 15 other studies in this databaseCounted from the lead sponsor named in the record (Stemline Therapeutics, Inc.)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourMODERATE

A moderately rigorous design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding0/20
Open-label
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
Multi-centre8/8
Multi-centre: 555 sites
Data monitoring committee0/7
Data monitoring committee not stated in the record
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 4,220 participants (target), run at 567 sites, across 28 countries.

How this score is built

Enrolment35/40
4,220 participants (target)
Site count25/25
555 sites
Country count15/15
28 countries
Planned duration10/10
Planned over about 98 months
Sponsor scale3/10
Stemline Therapeutics, Inc. has led 13 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

Conditions

Breast Cancer

Eligibility

Eligibility
Sex	All
Ages	18 Years – No maximum
Healthy volunteers	No

Eligibility as written in the registry

Key Inclusion Criteria: * Histopathologically or cytologically confirmed ER+ (≥10% by immunohistochemistry \[IHC\]), HER2- (tumors with an IHC score of 0, 1+, or 2+ with in situ hybridization \[ISH\]-negative \[not amplified\]). ISH-negative without IHC testing will also be eligible 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/College of American Pathologists guidelines. * Participants must be node positive (microscopic and macroscopic tumor involvement are allowed) and fulfill one of the following criteria: 1. ≥4 positive axillary lymph nodes or 2. 1-3 positive axillary lymph nodes and 1. Histologic grade 3 disease and/or 2. Tumor size ≥5 centimeters and/or 3. High genomic risk (identified by Oncotype, MammaPrint, EndoPredict, PAM50) * Participants who are currently taking endocrine therapy (aromatase inhibitors or tamoxifen) and have received at least 24 months but not more than 60 months of endocrine therapy at the time of randomization (Cycle 1 Day 1 \[C1D1\]) with or without a CDK 4 and CKD 6 inhibitor (CDK4/6i) and with or without a luteinizing hormone-releasing hormone agonist. * Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase inhibitor must have already completed or discontinued these treatments. Key Exclusion Criteria: * Participants with inflammatory breast cancer. * History of any prior (ipsilateral and/or contralateral) invasive breast cancer. * Participant with history of non-breast 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.

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Phase 3
Allocation	Randomised
Intervention model	PARALLEL
Primary purpose	TREATMENT
Masking	NONE (0)
Enrolment	4,220 participants sought

Sponsor and collaborators

Stemline Therapeutics, Inc. Sponsor

Arms and interventions

ElacestrantEXPERIMENTAL
Participants will receive 345 milligrams (mg) elacestrant once daily (QD) for 5 years.
Standard of Care (SoC) Endocrine TherapyEXPERIMENTAL
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

Interventions

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

Outcome measures

Primary outcome
Invasive Breast Cancer-Free Survival (IBCFS)
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
Time frame Up to 5 years
Secondary outcome
Distant Relapse-Free Survival (DRFS)
Assessed by the time from date of randomization to the date of first occurrence of: * Distant recurrence, or * Death attributable to any cause
Time frame Up to 5 years
Secondary outcome
Overall Survival (OS)
Time frame Up to 5 years
Secondary outcome
Invasive Disease-Free Survival (IDFS)
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
Time frame Up to 5 years
Secondary outcome
Number of Participants With Adverse Events (AEs)
Time frame Up to 5 years plus 28 days
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
Area Under the Plasma Concentration Versus Time Curve at Steady State (AUCss) of Elacestrant
Time frame Predose up to 4 hours postdose
Secondary outcome
Maximum Plasma Concentration at Steady State (Cmaxss) of Elacestrant
Time frame Predose up to 4 hours postdose

Dates

Dates
Start date	September 27, 2024 (actual)
Primary completion	August 1, 2029 (estimated)
Completion	October 1, 2032 (estimated)
First posted	July 9, 2024 (actual)
Last updated	September 15, 2026
Results posted	Not stated in the registry record
Status last verified	September 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

501 sites are recruiting

Argentina

Argentina
Facility	City	State or region	Status
(COIBA)Centro de Oncologia e Investigacion Buenos Aires	Berazategui	Buenos Aires	Recruiting
Clinica Adventista Belgrano	Buenos Aires	Tucumán Province	Recruiting
Fundacion Respirar	Buenos Aires	Buenos Aires F.D.	Recruiting
Organizacion Medica de Investigacion (OMI)	Buenos Aires	Buenos Aires F.D.	Recruiting
Instituto Argentino de Diagnostico y Tratamiento	Buenos Aires		Recruiting
Centro de Investigación CIPREC	C.a.b.a.	Buenos Aires F.D.	Recruiting
Centro Oncológico Korben	CABA	Buenos Aires F.D.	Recruiting
Centro Medico Privado CEMAIC	Córdoba	Córdoba Province	Recruiting
Inst Med Fund Estudios Clinicos	Rosario	Santa Fe Province	Recruiting
Instituto de Oncologia de Rosario	Rosario	Santa Fe Province	Recruiting
Centro Oncologico de Excelencia	San Juan		Recruiting

Australia

Australia
Facility	City	State or region	Status
Cancer Research SA	Adelaide	South Australia	Recruiting
Royal Adelaide Hospital - Oncology	Adelaide	South Australia	Recruiting
Icon Cancer Centre Wesley	Auchenflower	Queensland	Recruiting
Flinders Medical Centre	Bedford Park	South Australia	Recruiting
Box Hill Hospital	Box Hill	Victoria	Recruiting
Monash Medical Centre	Clayton	Victoria	Recruiting
St Vincent's Hospital Sydney	Darlinghurst	New South Wales	Recruiting
Northern Hospital	Epping	Victoria	Recruiting
Lake Macquarie Private Hospital - Oncology	Gateshead	New South Wales	Recruiting
Austin Health	Heidelberg		Recruiting
Icon Cancer Centre Hobart	Hobart		Recruiting
Icon Cancer Centre Townsville	Hyde Park	Queensland	Recruiting
St George Hospital - Medical Oncology	Kogarah	New South Wales	Recruiting
Icon Cancer Centre Kurralta Park	Kurralta Park	South Australia	Recruiting
Launceston General Hospital - Medical Oncology	Launceston	Tasmania	Recruiting
Lismore Base Hospital - Cancer Care , Haematology Unit	Lismore	New South Wales	Recruiting
Macquarie University	Macquarie Park	New South Wales	Recruiting
Maroondah Hospitals - Medical Oncology	Melbourne	Victoria	Recruiting
Breast Cancer Research Centre	Nedlands	Western Australia	Recruiting
Mater Hospital Sydney	North Sydney	New South Wales	Recruiting
Mid North Coast Cancer Institute	Port Macquarie		Recruiting
Goulburn Valley Health	Shepparton	Victoria	Recruiting
Icon Cancer Centre Southport	Southport	Queensland	Recruiting
Westmead Hospital	Westmead	New South Wales	Recruiting
The Queen Elizabeth Hospital	Woodville	South Australia	Recruiting

Austria

Austria
Facility	City	State or region	Status
Medizinische Universität Graz	Graz	Styria	Recruiting
Universitätsklinikum Krems	Krems	Lower Austria	Recruiting
LKH Hochsteiermark	Leoben	Styria	Recruiting
Universitatsklinikum St. Polten	Sankt Pölten	Lower Austria	Recruiting
Hanusch Krankenhaus	Vienna		Recruiting
Brustgesundheitszentrum Süd	Weiz	Styria	Recruiting

Belgium

Belgium
Facility	City	State or region	Status
Edith Cavell Inter-regional Hospital Centre (CHIREC) - Delta Hospital	Aalst	Brussels Capital	Recruiting
Algemeen Ziekenhuis Klina	Brasschaat	Antwerpen	Recruiting
Association Hospitaliere De Bruxelles Et De Schaerbeek - Centre Hospitalier Universitaire Brugmann	Brussels	Brussels Capital	Recruiting
Institut Jules Bordet	Brussels		Recruiting
CHU Saint-Pierre	Brussels	Brussels Capital	Recruiting
Grand Hopital de Charleroi - Site Les Viviers	Charleroi	Hainaut	Recruiting
Jessa Ziekenhuis - Campus Virga Jesse - Medische Oncologie	Hasselt	Limburg	Recruiting
UZ Leuven	Leuven	Vlaams Brabant	Recruiting

517 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

September 15, 2026
Site added
5 sites added (567 total)
562567
August 17, 2026
Site added
7 sites added (562 total)
555562

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06492616

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

Argentina

Australia

Austria

Belgium

Study documents

Changes over time