Eli Lilly And Company ((LLY)) announced an update on their ongoing clinical study.
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Eli Lilly and Company, in collaboration with Pfizer, is conducting a Phase 3 clinical study titled A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2). The study aims to evaluate the efficacy and safety of LY4064809 in combination with other anti-cancer treatments for advanced breast cancer patients with specific genetic mutations.
The study tests LY4064809, an oral drug, in combination with CDK4/6 inhibitors and endocrine therapy. These treatments are designed to target and manage advanced breast cancer effectively, potentially offering a new therapeutic option for patients with hormone receptor-positive, HER2-negative breast cancer.
This interventional study is randomized, with participants assigned to different treatment groups. It employs a double-blind design to ensure unbiased results, with both participants and investigators unaware of group assignments. The primary goal is treatment efficacy.
The study is set to begin recruiting participants on September 12, 2025, with the primary completion date yet to be determined. The last update was also submitted on September 12, 2025, indicating the study’s preparatory phase.
For investors, this study could signal potential growth for Eli Lilly, especially if the results demonstrate significant benefits. Positive outcomes may enhance investor confidence and influence stock performance. As the study involves collaboration with Pfizer, it may also impact the competitive landscape in the oncology sector.
The study is ongoing, with further details available on the ClinicalTrials portal.