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

Trial Details

NCT ID

NCT06492616

Phase

PHASE3

Sponsor

Stemline Therapeutics, Inc.

Status

RECRUITING

Cancer Type

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
• Phoenix, Arizona, United States|33.44838,-112.07404
• Scottsdale, Arizona, United States|33.50921,-111.89903

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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