OB/GYN & Women's Health
PHASE3
● Phase III
Raloxifene SNP Study: Investigating ER and UGT Gene Impact on Breast Cancer Outcomes
ClinicalTrials.gov
Published March 27, 2026
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
NCT06062810 ↗
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.
AI Accuracy Review: 8/10
· Auto-published
Imagine if a drug you take for breast cancer could work better just for you. That’s the hope behind a new study exploring Raloxifene, a medication often prescribed for breast cancer patients. Breast cancer, especially types like Lobular Carcinoma In Situ (LCIS), can be tricky to treat, and finding the right medication can feel overwhelming. This study aims to uncover how specific genetic variations—called single nucleotide polymorphisms (SNPs)—influence how well Raloxifene works and how safe it is for patients. By analyzing blood samples and breast tissue from 600 patients, researchers will look for patterns that could show which patients benefit most from this drug and who might face more side effects. If successful, this research could lead to personalized treatment plans, making Raloxifene more effective and safer for those fighting breast cancer. However, it’s important to remember that this is still in the early stages, and more research is needed before these insights can be applied in everyday care. The future of breast cancer treatment could be more tailored than ever, offering hope to many women.
What this means for you: Understanding genetic differences could make breast cancer treatment safer and more effective for patients.
View Original Abstract ↓
Status: ACTIVE_NOT_RECRUITING | Phase: PHASE2/PHASE3
Condition(s): Breast Cancer
Intervention(s): Raloxifene - Usual (DRUG), Raloxifene - Study (DRUG)
Explore the relationship between drug target ER gene single nucleotide polymorphisms and Raloxifene therapeutic effects in patients with Breast Cancer LCIS, based on Oxford precisely sequencing drug targets' genes.
Explore the relationship between drug target UGT gene single nucleotide polymorphisms and Raloxifene side-effects in patients with Breast Cancer LCIS, based on Oxford precisely sequencing drug targets' genes.
Detailed: The usual approach group, after breast tissue biopsy, 300 double blind random group separated BC-LCIS patients currently used the Chemotherapy on Generic-1 - raloxifene hydrochloride tablet, 60 mg daily, it will try to look for the relationship between the Raloxifene therapeutic efficacy and the ER SNP Genotyping, after blood draw, to look for the relationship between the Raloxifene therapeutic safety and the UGT SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.
The study approach group, after breast tissue biopsy, 300 double blind random group separated BC-LCIS patients currently used the Chemotherapy on Generic-2 - Raloxifene tablet, 60 mg daily, it will try to look for the relationship between the Raloxifene therapeutic efficacy and the ER SNP Genotyping, after
Primary Outcome(s): Measure and Report Raloxifene oncology drug target ER SNP Genotypes which are effectiveness associated.; Measure and Report Raloxifene oncology drug target UGT SNP Genotypes which are risk associated.
Enrollment: 600 (ESTIMATED)
Lead Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Start: 2025-06-21 | Primary Completion: 2026-12-18