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)

Brief description of study

This is a phase 3 study, comparing the new medicine called Elacestrant (selective estrogen receptor degrader) with standard hormonal treatments in patients with ER-positive/HER2-negative early breast cancer who have previously received at least 2 years of hormonal treatment after their surgery or first breast cancer treatment and are currently receiving hormonal treatment.

Patients will be divided into two groups. One group will receive the study medicine elacestrant, and the other group will continue the standard hormonal treatment they are already receiving. All patients will have their blood samples taken to see how their bodies are handling the medicine. Doctors will perform special scans at different times throughout the study to see how the patients are doing and if the study medicine is working better than the standard treatment. All patients will be closely watched for side effects and will be followed for 28 (+7) days after their last treatment.


Clinical Study Identifier: s24-01977
ClinicalTrials.gov Identifier: NCT06492616
Principal Investigator: Nancy Chan.
Other Investigators: Shridar Ganesan, Elizabeth Comen, Yan Fon Mei, Danielle Seidman, Natalie Jill Klar, Yelena Novik, Marleen I Meyers, Neil Vasan, Elena Katz, Yael Simons, Maryann J Kwa, Nina D'Abreo, Stephanie M Erichsen, Alana Grace Spadalik, Amanda Marie Buzolich, Anastasiya Apanasyuk, Ruth Oratz, Naomi Yu Ko, Ariel Karwat, Wanqing Iris Zhi, Phyu Phyu Soe, Douglas K Marks, Alexander A Hindenburg.


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