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Bioequivalence ANDA SNP Clinical Study - Raloxifene and Single Nucleotide Polymorphisms
Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
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.
Official title: Explore the Relationship Between Single Nucleotide Polymorphisms and Raloxifene Response and Toxicity in Patients With Breast Cancer LCIS
Key Details
Gender
FEMALE
Age Range
24 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2025-06-21
Completion Date
2026-12-28
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
Raloxifene - Usual
* Generic-1 - raloxifene hydrochloride tablet * Raloxifene 60 mg taken orally daily
Raloxifene - Study
* Generic-2 - Raloxifene tablet * Raloxifene 60 mg taken orally daily
Locations (1)
Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
Rockville, Maryland, United States