Comparing Elacestrant with Anastrozole for breast cancer
Official title: 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
Interventions
Elacestrant
Administered as oral tablets
Anastrozole
Administered as oral tablets
Letrozole
Administered as oral tablets
Exemestane
Administered as oral tablets
Tamoxifen
Administered as oral tablets
Canadian Sites (10)
Hôpital du Saint-Sacrement
Québec, Canada
BC Cancer -Surrey
Surrey, British Columbia, Canada
BC Cancer Agency
Vancouver, British Columbia, Canada
Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials
Barrie, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
St. Michaels Hospital
Toronto, Ontario, Canada
Mount Sinai Hospital - Study Supplies
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Centre hospitalier régional de Lanaudière
Saint-Charles-Borromée, Quebec, Canada
Regional Hospital Saint-Jerome
Saint-Jérôme, Quebec, Canada
Eligibility Criteria
See who this study is looking for9 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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
- −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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →, 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 SoCStandard of careThe treatment normally given for a condition outside a study.Read more → adjuvant endocrine therapy or who are off current adjuvant endocrine therapy more than 6 months prior to randomization
- −Note: Other protocolProtocolThe detailed plan a study must follow.Read more → defined InclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → may apply.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Elacestrant, Anastrozole, Letrozole, Exemestane, and 1 more.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 4,220 people.
The study is currently expected to finish around October 2032.
The main measurement is taken over: Up to 5 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Invasive Breast Cancer-Free Survival (IBCFS) — measured over Up to 5 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06492616 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About ElacestrantDrug
Administered as oral tablets
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About AnastrozoleDrug
Administered as oral tablets
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About LetrozoleDrug
Administered as oral tablets
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About ExemestaneDrug
Administered as oral tablets
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About TamoxifenDrug
Administered as oral tablets
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 5 years.
The study as a whole is currently expected to finish around 2032-10.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 4,220 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 29 locations, including: Québec, Canada; Surrey, British Columbia, Canada; Vancouver, British Columbia, Canada; Barrie, Ontario, Canada; London, Ontario, Canada; Toronto, Ontario, Canada, and 23 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (28)
The Cancer & Hematology Centers
Grand Rapids, Michigan, United States
Mayo Clinic Health System - Albert Lea
Albert Lea, Minnesota, United States
Mayo Clinic - Mankato
Mankato, Minnesota, United States
Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Metro-MN Comm. Onc. Res Consortium
Saint Louis Park, Minnesota, United States
Kings County Hospital Center
Brooklyn, New York, United States
Hematology Oncology Associates of Central New York, PC
East Syracuse, New York, United States
Cayuga Medical Center
Ithaca, New York, United States
NYU Langone Hospital-Long Island
Mineola, New York, United States
The Blavatnik Family - Chelsea Medical Center at Mount Sinai
New York, New York, United States
Laura and Isaac Perlmutter Cancer Center/NYU Langone Health
New York, New York, United States
Mount Sinai West
New York, New York, United States
Icahn School of Medicine Mount Sinai
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester Medical
Rochester, New York, United States
Stony Brook University Cancer Center
Stony Brook, New York, United States
Clinical Research Alliance, Inc.
Westbury, New York, United States
Fred Hutch CC at Evergreen HMC
Kirkland, Washington, United States
Vista Oncology
Olympia, Washington, United States
And 8 more sites worldwide.
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.