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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06492616




Registration number
NCT06492616
Ethics application status
Date submitted
1/07/2024
Date registered
9/07/2024
Date last updated
10/04/2025

Titles & IDs
Public title
A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
Scientific 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
Secondary ID [1] 0 0
STML-ELA-0422
Universal Trial Number (UTN)
Trial acronym
ELEGANT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Elacestrant
Treatment: Drugs - Anastrozole
Treatment: Drugs - Letrozole
Treatment: Drugs - Exemestane
Treatment: Drugs - Tamoxifen

Experimental: Elacestrant - Participants will receive 345 milligrams (mg) elacestrant once daily (QD) for 5 years

Experimental: Standard of Care (SoC) Endocrine Therapy - 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


Treatment: Drugs: Elacestrant
Administered as oral tablets

Treatment: Drugs: Anastrozole
Administered as oral tablets

Treatment: Drugs: Letrozole
Administered as oral tablets

Treatment: Drugs: Exemestane
Administered as oral tablets

Treatment: Drugs: Tamoxifen
Administered as oral tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Invasive Breast Cancer-Free Survival (IBCFS)
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Distant Relapse-Free Survival (DRFS)
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to 5 years
Secondary outcome [3] 0 0
Invasive Disease-Free Survival (IDFS)
Timepoint [3] 0 0
Up to 5 years
Secondary outcome [4] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [4] 0 0
Up to 5 years plus 28 days
Secondary outcome [5] 0 0
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)
Timepoint [5] 0 0
Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
Secondary outcome [6] 0 0
Change from Baseline in the Physical Functioning Sub-Scale Score as Assessed by EORTC QLQ-C30
Timepoint [6] 0 0
Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
Secondary outcome [7] 0 0
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)
Timepoint [7] 0 0
Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
Secondary outcome [8] 0 0
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)
Timepoint [8] 0 0
Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
Secondary outcome [9] 0 0
Area Under the Plasma Concentration Versus Time Curve at Steady State (AUCss) of Elacestrant
Timepoint [9] 0 0
Predose up to 4 hours postdose
Secondary outcome [10] 0 0
Maximum Plasma Concentration at Steady State (Cmaxss) of Elacestrant
Timepoint [10] 0 0
Predose up to 4 hours postdose

Eligibility
Key inclusion criteria
Key

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

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 discontinued adjuvant endocrine therapy more than 6 months prior to randomization

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2032
Actual
Sample size
Target
4220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,QuuenslandSA,VIC
Recruitment hospital [1] 0 0
Icon Cancer Centre Southport - Southport
Recruitment hospital [2] 0 0
Icon Cancer Centre Wesley - Auchenflower
Recruitment hospital [3] 0 0
Icon Cancer Centre Kurralta Park - Kurralta Park
Recruitment hospital [4] 0 0
Goulburn Valley Health - Shepparton
Recruitment hospital [5] 0 0
Icon Cancer Centre Hobart - Hobart
Recruitment hospital [6] 0 0
Mid North Coast Cancer Institute - Port Macquarie
Recruitment postcode(s) [1] 0 0
4215 - Southport
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [4] 0 0
3630 - Shepparton
Recruitment postcode(s) [5] 0 0
7000 - Hobart
Recruitment postcode(s) [6] 0 0
2444 - Port Macquarie
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Nebraska
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New Mexico
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
United States of America
State/province [25] 0 0
Wisconsin
Country [26] 0 0
Austria
State/province [26] 0 0
Wien
Country [27] 0 0
Canada
State/province [27] 0 0
Quebec
Country [28] 0 0
Germany
State/province [28] 0 0
Esslingen a.N.
Country [29] 0 0
Germany
State/province [29] 0 0
Fuerstenwalde /Spree
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Chungcheongbugdo [Ch'ungch'ongbuk-do]
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Incheon Gwang'yeogsi [Inch'n-Kwangyokshi]
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Busan
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Gyeonggi-do
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Ulsan
Country [36] 0 0
Malaysia
State/province [36] 0 0
Wilayah Persekutuan Kuala Lumpur
Country [37] 0 0
Malaysia
State/province [37] 0 0
Melaka
Country [38] 0 0
Netherlands
State/province [38] 0 0
Eindhoven
Country [39] 0 0
Poland
State/province [39] 0 0
Lodz
Country [40] 0 0
Romania
State/province [40] 0 0
Bucuresti
Country [41] 0 0
Romania
State/province [41] 0 0
Floresti
Country [42] 0 0
Spain
State/province [42] 0 0
Andalucia
Country [43] 0 0
Spain
State/province [43] 0 0
Córdoba
Country [44] 0 0
Spain
State/province [44] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Stemline Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Stemline Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Stemline Trials
Address 0 0
Country 0 0
Phone 0 0
1-877-332-7961
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06492616