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

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.

Trial Details

NCT ID

NCT06492616

Phase

PHASE3

Sponsor

Stemline Therapeutics, Inc.

Status

RECRUITING

Cancer Type

HER2 Positive Breast Cancer

Interventions

Elacestrant
Anastrozole
Letrozole
Exemestane
Tamoxifen

Locations (sample)

Daphne, Alabama, United States|30.60353,-87.9036
Chandler, Arizona, United States|33.30616,-111.84125
Gilbert, Arizona, United States|33.35283,-111.78903
Scottsdale, Arizona, United States|33.50921,-111.89903
Tucson, Arizona, United States|32.22174,-110.92648

Key Eligibility Criteria

Histopathologically or cytologically confirmed ER-positive (≥ 10% by immunohistochemistry \[IHC\]), HER2-negative \[IHC = 0, 1+, 2 and in situ hybr…
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 C…
Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor must have already completed or discontin…

For full eligibility, visit ClinicalTrials.gov.

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