{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Stearns V"],"funding":["NCI","Susan G. Komen","NCI NIH HHS"],"pagination":["595-602"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12167464"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["209(3)"],"pubmed_abstract":["<h4>Purpose</h4>In tamoxifen-treated individuals, reduced-function genetic variants in the CYP2D6 gene or inhibition of the enzyme result in low circulating endoxifen concentrations. We assessed the impact of reduced CYP2D6 activity and circulating endoxifen concentrations on breast cancer outcomes.<h4>Patients and methods</h4>Patients with locally advanced or stage IV hormone receptor-positive breast cancer were enrolled in this single arm phase II trial and received open label tamoxifen 20 mg PO daily. The primary objective was to assess CYP2D6 poor metabolizer (PM) vs intermediate and normal metabolizer status (IM + NM) with progression-free survival (PFS). CYP2D6 phenotype was determined from whole blood samples (Roche Amplichip), and secondary endpoint evaluated endoxifen concentratio"],"journal":["Breast cancer research and treatment"],"pubmed_title":["CYP2D6 activity in patients with metastatic breast cancer treated with single agent tamoxifen: results from ECOG-ACRIN E3108."],"pmcid":["PMC12167464"],"funding_grant_id":["U10 CA180794","UG1 CA233234","U10 CA180820","UG1 CA233196","UG1 CA232760"],"pubmed_authors":["Schneider BP","Silverman P","Moore DF","Vallejos CS","ONeill A","Liu MC","Cheema PS","Lohrisch C","Skaar TC","Sledge GW","Goetz MP","Villa D","Sparano JA","Stearns V"],"additional_accession":[]},"is_claimable":false,"name":"CYP2D6 activity in patients with metastatic breast cancer treated with single agent tamoxifen: results from ECOG-ACRIN E3108.","description":"<h4>Purpose</h4>In tamoxifen-treated individuals, reduced-function genetic variants in the CYP2D6 gene or inhibition of the enzyme result in low circulating endoxifen concentrations. We assessed the impact of reduced CYP2D6 activity and circulating endoxifen concentrations on breast cancer outcomes.<h4>Patients and methods</h4>Patients with locally advanced or stage IV hormone receptor-positive breast cancer were enrolled in this single arm phase II trial and received open label tamoxifen 20 mg PO daily. The primary objective was to assess CYP2D6 poor metabolizer (PM) vs intermediate and normal metabolizer status (IM + NM) with progression-free survival (PFS). CYP2D6 phenotype was determined from whole blood samples (Roche Amplichip), and secondary endpoint evaluated endoxifen concentratio","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 Feb","modification":"2026-06-01T13:51:08.086Z","creation":"2026-04-08T13:18:10.499Z"},"accession":"S-EPMC12167464","cross_references":{"pubmed":["39432161"],"doi":["10.1007/s10549-024-07519-z"]}}