Bioequivalence ANDA SNP Clinical Study - Raloxifene and Single Nucleotide Polymorphisms

NCT06062810 · tracked via the Priya Life Science USA tracker

Sponsor

Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Phase

Phase 2/3

Started

2025-06-21

Last updated

2026-04-23

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Raloxifene - UsualRaloxifene - Study

Raloxifene - Usual: * Generic-1 - raloxifene hydrochloride tablet * Raloxifene 60 mg x 2 taken orally daily

Raloxifene - Study: * Generic-2 - Raloxifene Hydrochloride Tablet * Raloxifene 60 mg x 2 taken orally daily

Study 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.

Eligibility

Sex

FEMALE

Min age

24 Years

Max age

64 Years

Healthy volunteers

* Select 600 Breast Cancer LCIS Patients who are suitable for breast tissue biopsy * High risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (LCIS) * Dosage Duration at least 90 days * The usual approach group - Recruit 300 double blind random group separated BC-LCIS patients currently used the Chemotherapy Dose on Generic-1 - raloxifene hydrochloride tablet, after breast tissue biopsy, and, after blood draw, like as the usual approach group. * The study approach group - Recruit 300 double blind random group separated BC-LCIS patients currently used the Chemotherapy Dose on Generic-2 - raloxifene tablet, after breast tissue biopsy, and, after blood draw, like as the study approach group. Inclusion Criteria: 1. Clinical diagnosis of Breast Cancer LCIS 2. Clinical breast tissue biopsy diagnosis showing lobular carcinoma in situ (LCIS) 3. Suitable for enough breast tissue biopsy of Breast Cancer LCIS 4. Random and double blind 5. Measurable disease 6. Adequate organ functions 7. Adequate performance status 8. Age 22 years old and over 9. Sign an informed consent form 10. Receive blood-drawing Exclusion Criteria: 1. Mastectomy 2. Treatment with other anti-cancer therapies and cannot be stopped currently 3. Pregnancy 4. Breast-feeding 5. The patients with other serious intercurrent illness or infectious diseases 6. Have more than one different kind of cancer at the same time 7. Serious Allergy to Drugs 8. Thrombus or Bleed Tendency 9. Serious Risks or Serious Adverse Events of the drug product 10. The prohibition of drug products 11. Have no therapeutic effects 12. Follow up to the most current label

Primary outcome measure(s)

Measure and Report Raloxifene oncology drug target ER SNP Genotypes which are effectiveness associated. — Up to 12 weeks
* Recruit 300 double blind random group separated Breast Cancer LCIS patients currently using the Chemotherapy dose on Generic-1 - raloxifene (60mg x 2 orally daily), after breast tissue biopsy, to be the usual approach group. * Recruit 300 double blind random group separated Breast Cancer LCIS patients currently using the Chemotherapy dose on Generic-2 - raloxifene (60mg x 2 orally daily), after breast tissue biopsy, to be the study approach group. * Measure above every BC-LCIS patient specific Raloxifene oncology drug target ER SNP genotype in Breast Cancer cell whole genome DNA with Oxford precisely sequencing. * Report every BC-LCIS patient specific ER SNP genotype in whole genome DNA sequence.
Measure and Report Raloxifene oncology drug target UGT SNP Genotypes which are risk associated. — Up to 12 weeks
* Recruit 300 double blind random group separated Breast Cancer LCIS patients currently using the Chemotherapy dose on Generic-1 - raloxifene (60mg x 2 orally daily), after blood draw, to be the usual approach group. * Recruit 300 double blind random group separated Breast Cancer LCIS patients currently using the Chemotherapy dose on Generic-2 - raloxifene (60mg x 2 orally daily), after blood draw, to be the study approach group. * Measure above every BC-LCIS patient specific Raloxifene oncology drug target UGT SNP genotype in WBC cell whole genome DNA with Oxford precisely sequencing. * Report every BC-LCIS patient specific UGT SNP genotype in whole genome DNA sequence.

Trial sites (1)

Facility	City	Region	Status
Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701	Rockville	Maryland

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06062810 on ClinicalTrials.gov ↗ ← All trials in the USA