<?xml version="1.0" encoding="UTF-8"?><protocol_summary><protocol><id>17049</id><no>J6M-MC-JSGD-NCT07174336</no><status>Open</status><title>A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined &#xD;
with a CDK4/6 Inhibitor and Endocrine Therapy in Adults with HR+, HER2- Advanced Breast &#xD;
Cancer with a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)&#xD;
</title><secondary_protocol_no>J6M-MC-JSGD</secondary_protocol_no><nct_id>NCT07174336</nct_id><sponsor_type>Industrial</sponsor_type><age_group>Adult</age_group><treatment_type>Treatment</treatment_type><phase>III</phase><scope>Global</scope><disease_site>Breast</disease_site><PI>Chitalia, Ami</PI><institution>MedStar Health and GUMC; Medstar Washington Hospital Center</institution><oncology_group>Breast<DOWG_name>Oncology Group</DOWG_name></oncology_group><management_group>MHRI Washington Cancer Institute</management_group></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>