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

NCT06492616
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
4,220
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Lead sponsor
Stemline Therapeutics, Inc.
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Start date
2024-09-27
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Number of sites
562
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Summary
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.
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Acronym
ELEGANT
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Short title
A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
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Official 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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2032-10-01
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First posted
2024-07-09
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Registry last updated
2026-08-17
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Primary completion date
2029-08-01
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Start date
2024-09-27
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Participants
4,220
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Participant count basis
Estimated
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Planned participants
4,220
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Protocol amendments
2
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Number of sites
562
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Registry sponsor category
Industry
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Lead sponsor
Stemline Therapeutics, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06492616
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ClinicalTrials.gov ID
NCT06492616
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Invasive Breast Cancer-Free Survival (IBCFS)

    Timeframe: Up to 5 years

    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

  1. Distant Relapse-Free Survival (DRFS)

    Timeframe: Up to 5 years

    Assessed by the time from date of randomization to the date of first occurrence of: * Distant recurrence, or * Death attributable to any cause

  2. Overall Survival (OS)

    Timeframe: Up to 5 years

  3. Invasive Disease-Free Survival (IDFS)

    Timeframe: Up to 5 years

    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

  4. Number of Participants With Adverse Events (AEs)

    Timeframe: Up to 5 years plus 28 days

  5. 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)

    Timeframe: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5

  6. Change from Baseline in the Physical Functioning Sub-Scale Score as Assessed by EORTC QLQ-C30

    Timeframe: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5

  7. 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)

    Timeframe: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5

  8. 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)

    Timeframe: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5

  9. Area Under the Plasma Concentration Versus Time Curve at Steady State (AUCss) of Elacestrant

    Timeframe: Predose up to 4 hours postdose

  10. Maximum Plasma Concentration at Steady State (Cmaxss) of Elacestrant

    Timeframe: Predose up to 4 hours postdose

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

Key Inclusion Criteria:

  • 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.

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 are off current adjuvant endocrine therapy more than 6 months prior to randomization

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

Sources for eligibility
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  • Southern Cancer Center, PCDaphne, United StatesRecruiting
  • Ironwood Cancer and Research CentersChandler, United StatesRecruiting
  • Banner MD Anderson Cancer CenterGilbert, United StatesRecruiting
  • Banner University Medical Center - Phoenix Campus (Banner Good Samaritan Medical Center)Phoenix, United StatesRecruiting
  • Mayo ClinicScottsdale, United StatesRecruiting
  • Arizona Clinical Research Center, Inc.Tucson, United StatesRecruiting
  • University of Arizona Cancer CenterTucson, United StatesRecruiting
  • Highlands Oncology Group, PASpringdale, United StatesRecruiting
  • Comprehensive Blood & Cancer CenterBakersfield, United StatesRecruiting
  • UCSF Cancer Center BerkeleyBerkeley, United StatesRecruiting
  • Cedars-Sinai Cancer Beverly HillsBeverly Hills, United StatesRecruiting
  • City of Hope National Medical CenterDuarte, United StatesRecruiting
  • UCSF Wash Cancer CNTRFremont, United StatesRecruiting
  • City of Hope at Irvine LennarIrvine, United StatesRecruiting
  • UC San Diego Moores Cancer CenterLa Jolla, United StatesRecruiting
  • Helios Clinical ResearchLong Beach, United StatesRecruiting
  • Cancer and Blood Research Center, LLCLos Alamitos, United StatesRecruiting
  • USC/Norris Comprehensive Cancer CenterLos Angeles, United StatesRecruiting
  • UCLA Department of Medicine - Hematology/OncologyLos Angeles, United StatesRecruiting
  • Pacific Cancer Care - OncologyMonterey, United StatesRecruiting
  • Hoag Memorial Hospital PresbyterianNewport Beach, United StatesRecruiting
  • UC Irvine Health, Chao Family Comprehensive Cancer CenterOrange, United StatesRecruiting
  • Stanford Women's Cancer CenterPalo Alto, United StatesRecruiting
  • Dignity Health dba Health Research InstituteSacramento, United StatesRecruiting
  • Sutter Institute for Medical ResearchSacramento, United StatesRecruiting

And 537 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2024-515445-42-00
Sources for references
clinicaltrials.gov

Related records

Drugs (5)

Lead sponsors (1)

Conditions (2)

Targets (2)