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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4,220
Administered as oral tablets
Administered as oral tablets
Administered as oral tablets
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
Time frame: Up to 5 years
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
Time frame: Up to 5 years
Overall Survival (OS)
Time frame: Up to 5 years
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
Time frame: Up to 5 years
Number of Participants With Adverse Events (AEs)
Time frame: Up to 5 years plus 28 days
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)
Time frame: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
Change from Baseline in the Physical Functioning Sub-Scale Score as Assessed by EORTC QLQ-C30
Time frame: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
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Administered as oral tablets
Administered as oral tablets
Southern Cancer Center, PC
Daphne, Alabama, United States
RECRUITINGIronwood Cancer and Research Centers
Chandler, Arizona, United States
RECRUITINGBanner MD Anderson Cancer Center
Gilbert, Arizona, United States
RECRUITINGMayo Clinic
Scottsdale, Arizona, United States
RECRUITINGArizona Clinical Research Center, Inc.
Tucson, Arizona, United States
RECRUITINGUniversity of Arizona Cancer Center
Tucson, Arizona, United States
RECRUITINGHighlands Oncology Group, PA
Springdale, Arkansas, United States
RECRUITINGComprehensive Blood & Cancer Center
Bakersfield, California, United States
RECRUITINGUCSF Cancer Center Berkeley
Berkeley, California, United States
RECRUITINGCity of Hope National Medical Center
Duarte, California, United States
RECRUITING...and 523 more locations
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)
Time frame: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
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)
Time frame: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
Area Under the Plasma Concentration Versus Time Curve at Steady State (AUCss) of Elacestrant
Time frame: Predose up to 4 hours postdose
Maximum Plasma Concentration at Steady State (Cmaxss) of Elacestrant
Time frame: Predose up to 4 hours postdose