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PIKALO-1: Phase I/II Trial of PI3Kα Inhibitor LY4064809 for HR+, HER2-Negative PIK3CA-Mutant Advanced Breast Cancer

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Slideset

In the PIKALO-1 trial conducted in patients with PIK3CA-mutated HR-positive/HER2-negative advanced breast cancer, LY4064809 was well tolerated with low risk of PI3Kα inhibitor class toxicities, when administered alone or in combination with fulvestrant or ET and a CDK4/6 inhibitor.

Released: December 22, 2025

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Provided by

Provided by Clinical Care Options, LLC dba Decera Clinical Education

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Supporters

Supported by educational grants from AstraZeneca, Daiichi Sankyo, Inc, Genentech, a member of the Roche Group, Gilead Sciences, Inc., Lilly, Novartis Pharmaceuticals Corporation, and Stemline Therapeutics, Inc.

AstraZeneca

Daiichi Sankyo, Inc.

Genentech, a member of the Roche Group

Gilead Sciences, Inc.

Lilly

Novartis Pharmaceuticals Corporation

Stemline Therapeutics, Inc.

Target Audience

This activity is intended for oncologists and other healthcare professionals who care for patients with breast cancer.

Learning Objectives

Upon completion of this activity, participants should be able to:

  • Identify subpopulations of patients with breast cancer most likely to benefit from a specific treatment plan based on predictive biomarkers

  • Apply recently presented data to clinical practice to expand treatment options and improve outcomes for patients with breast cancer
  • Evaluate new data on novel agents and therapeutic approaches for patients with breast cancer