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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.

التواصل مع هذه الدراسة

باختصار

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.

المرحلة 3مطلوب 4,220 مشاركاً567 موقعاً28 دولة

الفئات

علم الأورام63%الغدد الصمّاء والأيض22%الأمراض الجلدية15%

مسجَّلة في سجل واحد

ClinicalTrials.govNCT06492616فتح هذا السجل في ClinicalTrials.govتمت المزامنة قبل 5 أيام

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

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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.

ملخص

الحالات

Breast Cancer

الأهلية

الأهلية
الجنس	الجميع
الأعمار	18 Years – لا حد أقصى
المتطوعون الأصحّاء	لا

الأهلية كما كُتبت في السجل

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.

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

تصميم الدراسة
نوع الدراسة	تدخّلية
المرحلة	المرحلة 3
التخصيص	معشّاة
نموذج التدخّل	PARALLEL
الغرض الأساسي	TREATMENT
التعمية	NONE (0)
التجنيد	مطلوب 4,220 مشاركاً

الجهة الراعية والمتعاونون

Stemline Therapeutics, Inc. الجهة الراعية

الأذرع والتدخلات

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

التدخلات

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

مقاييس النتائج

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

التواريخ

التواريخ
تاريخ البدء	27 سبتمبر 2024 (فعلي)
الإتمام الأولي	1 أغسطس 2029 (تقديري)
الإتمام	1 أكتوبر 2032 (تقديري)
أول نشر	9 يوليو 2024 (فعلي)
آخر تحديث	15 سبتمبر 2026
النتائج منشورة	غير مذكور في سجل السجل
آخر تأكيد للحالة	سبتمبر 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

501 موقع قيد التجنيد

Argentina

Argentina
المنشأة	المدينة	الولاية أو المنطقة	الحالة
(COIBA)Centro de Oncologia e Investigacion Buenos Aires	Berazategui	Buenos Aires	قيد التجنيد
Clinica Adventista Belgrano	Buenos Aires	Tucumán Province	قيد التجنيد
Fundacion Respirar	Buenos Aires	Buenos Aires F.D.	قيد التجنيد
Organizacion Medica de Investigacion (OMI)	Buenos Aires	Buenos Aires F.D.	قيد التجنيد
Instituto Argentino de Diagnostico y Tratamiento	Buenos Aires		قيد التجنيد
Centro de Investigación CIPREC	C.a.b.a.	Buenos Aires F.D.	قيد التجنيد
Centro Oncológico Korben	CABA	Buenos Aires F.D.	قيد التجنيد
Centro Medico Privado CEMAIC	Córdoba	Córdoba Province	قيد التجنيد
Inst Med Fund Estudios Clinicos	Rosario	Santa Fe Province	قيد التجنيد
Instituto de Oncologia de Rosario	Rosario	Santa Fe Province	قيد التجنيد
Centro Oncologico de Excelencia	San Juan		قيد التجنيد

Australia

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

Austria

Austria
المنشأة	المدينة	الولاية أو المنطقة	الحالة
Medizinische Universität Graz	Graz	Styria	قيد التجنيد
Universitätsklinikum Krems	Krems	Lower Austria	قيد التجنيد
LKH Hochsteiermark	Leoben	Styria	قيد التجنيد
Universitatsklinikum St. Polten	Sankt Pölten	Lower Austria	قيد التجنيد
Hanusch Krankenhaus	Vienna		قيد التجنيد
Brustgesundheitszentrum Süd	Weiz	Styria	قيد التجنيد

Belgium

Belgium
المنشأة	المدينة	الولاية أو المنطقة	الحالة
Edith Cavell Inter-regional Hospital Centre (CHIREC) - Delta Hospital	Aalst	Brussels Capital	قيد التجنيد
Algemeen Ziekenhuis Klina	Brasschaat	Antwerpen	قيد التجنيد
Association Hospitaliere De Bruxelles Et De Schaerbeek - Centre Hospitalier Universitaire Brugmann	Brussels	Brussels Capital	قيد التجنيد
Institut Jules Bordet	Brussels		قيد التجنيد
CHU Saint-Pierre	Brussels	Brussels Capital	قيد التجنيد
Grand Hopital de Charleroi - Site Les Viviers	Charleroi	Hainaut	قيد التجنيد
Jessa Ziekenhuis - Campus Virga Jesse - Medische Oncologie	Hasselt	Limburg	قيد التجنيد
UZ Leuven	Leuven	Vlaams Brabant	قيد التجنيد

يُدرَج 517 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

15 سبتمبر 2026
أُضيف موقع
5 sites added (567 total)
562567
17 أغسطس 2026
أُضيف موقع
7 sites added (562 total)
555562

السجل: ClinicalTrials.gov · NCT########

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