Clinical Trial

BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer

Unknown Phase 1
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Summary
This phase I trial studies the side effects and best dose of the PI3K inhibitor BYL719 when given together with letrozole in treating patients with hormone receptor-positive metastatic breast cancer. The PI3K inhibitor BYL719 may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving the PI3K inhibitor BYL719 together with letrozole may kill more tumor cells
Protocol Amendment History 1 change
critical Trial status changed: Active, Not Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT01791478
Lead Sponsor Vanderbilt-Ingram Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Invasive Ductal Breast Carcinoma, Progesterone Receptor-positive Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer
Enrollment 46 participants
Start Date 2013-04
Primary Completion 2014-12 (estimated)
Study Completion 2025-02-28 (estimated)
Updated on ClinicalTrials.gov 2024-07-23