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

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.

יצירת קשר עם המחקר

בקצרה

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.

שלב 3דרושים 4,220 משתתפים567 אתרים28 מדינות

קטגוריות

אונקולוגיה63%אנדוקריני ומטבולי22%רפואת עור15%

רשום במרשם אחד

ClinicalTrials.govNCT06492616פתיחת רשומה זו ב־ClinicalTrials.govסונכרן לפני 5 ימים

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

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.

תקציר

מצבים רפואיים

Breast Cancer

זכאות

זכאות
מין	הכול
גילאים	18 Years – ללא מקסימום
מתנדבים בריאים	לא

זכאות כפי שנכתבה במרשם

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.

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

תכנון המחקר
סוג המחקר	התערבותי
שלב	שלב 3
הקצאה	אקראי
מודל ההתערבות	PARALLEL
מטרה ראשית	TREATMENT
הסתרה	NONE (0)
גיוס	דרושים 4,220 משתתפים

נותן חסות ושותפים

Stemline Therapeutics, Inc. נותן חסות

זרועות והתערבויות

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

התערבויות

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

מדדי תוצאה

מדד תוצאה ראשוני
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
מסגרת זמן Up to 5 years
מדד תוצאה משני
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
מסגרת זמן Up to 5 years
מדד תוצאה משני
Overall Survival (OS)
מסגרת זמן Up to 5 years
מדד תוצאה משני
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
מסגרת זמן Up to 5 years
מדד תוצאה משני
Number of Participants With Adverse Events (AEs)
מסגרת זמן Up to 5 years plus 28 days
מדד תוצאה משני
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)
מסגרת זמן Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
מדד תוצאה משני
Change from Baseline in the Physical Functioning Sub-Scale Score as Assessed by EORTC QLQ-C30
מסגרת זמן Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
מדד תוצאה משני
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)
מסגרת זמן Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
מדד תוצאה משני
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)
מסגרת זמן Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
מדד תוצאה משני
Area Under the Plasma Concentration Versus Time Curve at Steady State (AUCss) of Elacestrant
מסגרת זמן Predose up to 4 hours postdose
מדד תוצאה משני
Maximum Plasma Concentration at Steady State (Cmaxss) of Elacestrant
מסגרת זמן Predose up to 4 hours postdose

תאריכים

תאריכים
תאריך התחלה	27 בספטמבר 2024 (בפועל)
סיום ראשוני	1 באוגוסט 2029 (משוער)
סיום	1 באוקטובר 2032 (משוער)
פורסם לראשונה	9 ביולי 2024 (בפועל)
עודכן לאחרונה	15 בספטמבר 2026
התוצאות פורסמו	לא צוין ברשומת המרשם
המצב אומת לאחרונה	ספטמבר 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

501 אתרים מגייסים

Argentina

Argentina
מתקן	עיר	מדינה או אזור	מצב
(COIBA)Centro de Oncologia e Investigacion Buenos Aires	Berazategui	Buenos Aires	מגייס
Clinica Adventista Belgrano	Buenos Aires	Tucumán Province	מגייס
Fundacion Respirar	Buenos Aires	Buenos Aires F.D.	מגייס
Organizacion Medica de Investigacion (OMI)	Buenos Aires	Buenos Aires F.D.	מגייס
Instituto Argentino de Diagnostico y Tratamiento	Buenos Aires		מגייס
Centro de Investigación CIPREC	C.a.b.a.	Buenos Aires F.D.	מגייס
Centro Oncológico Korben	CABA	Buenos Aires F.D.	מגייס
Centro Medico Privado CEMAIC	Córdoba	Córdoba Province	מגייס
Inst Med Fund Estudios Clinicos	Rosario	Santa Fe Province	מגייס
Instituto de Oncologia de Rosario	Rosario	Santa Fe Province	מגייס
Centro Oncologico de Excelencia	San Juan		מגייס

Australia

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

Austria

Austria
מתקן	עיר	מדינה או אזור	מצב
Medizinische Universität Graz	Graz	Styria	מגייס
Universitätsklinikum Krems	Krems	Lower Austria	מגייס
LKH Hochsteiermark	Leoben	Styria	מגייס
Universitatsklinikum St. Polten	Sankt Pölten	Lower Austria	מגייס
Hanusch Krankenhaus	Vienna		מגייס
Brustgesundheitszentrum Süd	Weiz	Styria	מגייס

Belgium

Belgium
מתקן	עיר	מדינה או אזור	מצב
Edith Cavell Inter-regional Hospital Centre (CHIREC) - Delta Hospital	Aalst	Brussels Capital	מגייס
Algemeen Ziekenhuis Klina	Brasschaat	Antwerpen	מגייס
Association Hospitaliere De Bruxelles Et De Schaerbeek - Centre Hospitalier Universitaire Brugmann	Brussels	Brussels Capital	מגייס
Institut Jules Bordet	Brussels		מגייס
CHU Saint-Pierre	Brussels	Brussels Capital	מגייס
Grand Hopital de Charleroi - Site Les Viviers	Charleroi	Hainaut	מגייס
Jessa Ziekenhuis - Campus Virga Jesse - Medische Oncologie	Hasselt	Limburg	מגייס
UZ Leuven	Leuven	Vlaams Brabant	מגייס

517 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

15 בספטמבר 2026
אתר נוסף
5 sites added (567 total)
562567
17 באוגוסט 2026
אתר נוסף
7 sites added (562 total)
555562

מרשם: ClinicalTrials.gov · NCT########

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