Raloxifene SNP Study: Investigating ER and UGT Gene Impact on Breast Cancer Outcomes
This ongoing Phase 2/3 study investigates the pharmacogenomic relationship between specific single nucleotide polymorphisms (SNPs) in estrogen receptor (ER) and UDP-glucuronosyltransferase (UGT) genes and the therapeutic efficacy and safety of Raloxifene in patients with breast cancer lobular carcinoma in situ (BC-LCIS). The study involves 600 participants, randomly assigned to receive either a generic form of Raloxifene hydrochloride or another Raloxifene formulation, both administered at 60 mg daily. The primary endpoints are to identify ER SNP genotypes associated with therapeutic efficacy and UGT SNP genotypes linked to adverse effects. The study employs precise gene sequencing techniques to correlate genetic variations with clinical outcomes. While the study is not yet recruiting, it aims to provide insights into personalized treatment approaches based on genetic profiling. Safety data and adverse event profiles are being closely monitored, although specific statistics and outcomes are not yet available. The study's completion is anticipated by December 2026, with potential implications for tailoring breast cancer treatment based on genetic markers.