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 (ELEGANT)
- Conditions
- Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence
- Registration Number
- 2024-515445-42-00
- Lead Sponsor
- Stemline Therapeutics Inc.
- Brief Summary
Evaluate the efficacy of elacestrant relative to standard endocrine therapy in terms of Invasive breast cancer-free survival (IBCFS) in participants with node-positive, estrogen receptor-positive, HER2-negative early breast cancer with high risk of recurrence.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Not specified
- Target Recruitment
- 1972
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 who have received at least 24 months but not more than 60 months of endocrine therapy (AIs or tamoxifen) with or without a CDK4/6i and with or without an LHRH agonist. Participants who received prior CDK4/6i or a poly ADP-ribose polymerase (PARP) inhibitor must have already completed or discontinued these treatments.
Participants with inflammatory breast cancer.
History of any prior (ipsilateral and/or contralateral) invasive breast cancer.
Participants who had more than 6-month continuous interruption of prior SoC adjuvant endocrine therapy or who discontinued adjuvant endocrine therapy more than 6 months prior to randomization.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method IBCFS: 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. IBCFS: 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.
- Secondary Outcome Measures
Name Time Method DRFS: the time from randomization to distant recurrence or death from any cause, whichever occurred first. DRFS: the time from randomization to distant recurrence or death from any cause, whichever occurred first.
OS: the time from randomization to death from any cause. OS: the time from randomization to death from any cause.
IDFS: the time from randomization to the first occurrence of local or regional recurrence, contralateral recurrence, second primary non-breast invasive cancer, distant recurrence, or death attributable to any cause. IDFS: the time from randomization to the first occurrence of local or regional recurrence, contralateral recurrence, second primary non-breast invasive cancer, distant recurrence, or death attributable to any cause.
Adverse events (AEs), treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) as well as changes in clinical laboratory values and vital sign measurements. Adverse events (AEs), treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) as well as changes in clinical laboratory values and vital sign measurements.
Change from baseline in the global health status quality of life scale score at 6 and 12 months and annually thereafter, as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Change from baseline in the global health status quality of life scale score at 6 and 12 months and annually thereafter, as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Change from baseline in the physical functioning sub-scale score at 6 and 12 months and annually thereafter, as assessed by EORTC QLQ-C30. Change from baseline in the physical functioning sub-scale score at 6 and 12 months and annually thereafter, as assessed by EORTC QLQ-C30.
Change from baseline in the breast cancer Endocrine Therapy Symptoms sub-scale score at 6 and 12 months and annually thereafter, as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer module (EORTC QLQ-BR42). Change from baseline in the breast cancer Endocrine Therapy Symptoms sub-scale score at 6 and 12 months and annually thereafter, as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer module (EORTC QLQ-BR42).
Change from baseline in side effects/tolerability at 6 and 12 months and annually thereafter, as assessed by the Question 168 of the European Organization for the Research and Treatment of Cancer Question Library (EORTC Q168). Change from baseline in side effects/tolerability at 6 and 12 months and annually thereafter, as assessed by the Question 168 of the European Organization for the Research and Treatment of Cancer Question Library (EORTC Q168).
Elacestrant PK parameters, exposure-response analyses between elacestrant PK and efficacy/safety endpoints. Elacestrant PK parameters, exposure-response analyses between elacestrant PK and efficacy/safety endpoints.
Trial Locations
- Locations (365)
Southern Cancer Center, PC
🇺🇸Daphne, Alabama, United States
Ironwood Cancer and Research Centers
🇺🇸Chandler, Arizona, United States
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Arizona Clinical Research Center, Inc.
🇺🇸Tucson, Arizona, United States
Highlands Oncology Group, PA
🇺🇸Springdale, Arkansas, United States
UC San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
Cancer and Blood Research Center, LLC
🇺🇸Los Alamitos, California, United States
UCLA Department of Medicine - Hematology/Oncology
🇺🇸Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
Scroll for more (355 remaining)Southern Cancer Center, PC🇺🇸Daphne, Alabama, United StatesMichael MeshadPrincipal Investigator