NCT06062810

Bioequivalence ANDA SNP Clinical Study - Raloxifene and Single Nucleotide Polymorphisms

Explore the Relationship Between Single Nucleotide Polymorphisms and Raloxifene Response and Toxicity in Patients With Breast Cancer LCIS

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair · Industry
• Sex: Female
• Age: 24 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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 description

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 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. 1. Detect drug target whole gene precision sequence of everyone patient for all 600 recruited double-blind BC-LCIS patients. 2. Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double-blind BC-LCIS patients. 3. Calculate drug target gene SNPs in all 600 recruited double-blind BC-LCIS patients. 4. Correlate everyone patient drug target gene SNP to everyone patient drug efficacy. 5. Correlate everyone patient drug target gene SNP to everyone patient drug safety. 6. Mutually compare the usual approach group SNPs (300 double blind random group separated BC-LCIS patients) with the study approach group SNPs (300 double blind random group separated BC-LCIS patients). 7. Confirm the relationship between drug target gene SNPs and drug efficacy. 8. Confirm the relationship between drug target gene SNPs and drug safety.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Raloxifene - Usual	* Generic-1 - raloxifene hydrochloride tablet * Raloxifene 60 mg taken orally daily
DRUG	Raloxifene - Study	* Generic-2 - Raloxifene tablet * Raloxifene 60 mg taken orally daily

Timeline

• Start date: 2025-06-21
• Primary completion: 2026-12-18
• Completion: 2026-12-28
• First posted: 2023-10-02
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study