Stemline ((STML)) announced an update on their ongoing clinical study.
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Stemline Therapeutics, Inc. is conducting a pivotal Phase 3 study titled ‘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.’ The study aims to assess the effectiveness of elacestrant compared to standard endocrine therapies in reducing recurrence risks in this specific patient group.
The study tests two interventions: elacestrant, an oral drug administered daily at 345 mg for five years, and standard endocrine therapies, which include anastrozole, letrozole, exemestane, or tamoxifen, also administered orally.
This interventional study is randomized with a parallel assignment model and no masking, focusing primarily on treatment outcomes. It seeks to provide insights into better management of early breast cancer with high recurrence risk.
The study officially started on September 27, 2024, with the latest update submitted on July 8, 2025. These dates are crucial as they mark the progression and current status of the study, which is actively recruiting participants.
The outcome of this study could significantly influence Stemline’s market position, potentially boosting investor confidence and impacting stock performance positively. As the study progresses, it may also affect competitive dynamics within the oncology sector.
The study is ongoing, with further details available on the ClinicalTrials portal.