<?xml version="1.0" encoding="UTF-8"?><protocol_summary><protocol><id>16215</id><no>STML-ELA-0422-NCT06492616</no><status>Open (affiliates only)</status><title>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</title><secondary_protocol_no>STML-ELA-0422</secondary_protocol_no><nct_id>NCT06492616</nct_id><sponsor_type>Industrial</sponsor_type><age_group>Adult</age_group><treatment_type>Treatment</treatment_type><phase>III</phase><disease_site>Other</disease_site><PI>Khoury, Katia</PI><institution>Georgetown University Medical Center : Julie Castle, Antonella Novielli; Lombardi Comprehensive Cancer Center : Julie Castle, Antonella Novielli</institution><oncology_group>Breast<DOWG_name>Oncology Group</DOWG_name></oncology_group><management_group>Lombardi Comprehensive Cancer Center (LCCC); Oncology PFS</management_group><item><contact_id>7263</contact_id><item_description>Julie Castle</item_description><js_safe_str>Julie Castle</js_safe_str><phone_no>+1 202-687-2209</phone_no><email>bickmorj@georgetown.edu</email><title>Clinical Research Nurse </title></item><item><contact_id>7311</contact_id><item_description>Antonella Novielli</item_description><js_safe_str>Antonella Novielli</js_safe_str><phone_no>+1 202-784-3923</phone_no><fax_no>+1 202-687-3372</fax_no><email>noviella@georgetown.edu</email><title>Clinical Research Nurse </title></item></protocol><sipVersion>2026.1.0 Build 16</sipVersion><copyright> &lt;a href="https://advarra.com" target="_blank"&gt;&amp;copy; 2026 Advarra, Inc.&lt;/a&gt; </copyright></protocol_summary>