Bioequivalence ANDA SNP Clinical Study - Raloxifene and Single Nucleotide Polymorphisms (Drugs-SNPs)

April 18, 2026 updated by: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 x 2 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 Hydrochloride Tablet, 60 mg x 2 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.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Rockville, Maryland, United States, 20853
        • Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Raloxifene - Usual
  • Generic-1 - Raloxifene
  • Chemotherapy
  • Generic-1 - raloxifene hydrochloride tablet
  • Raloxifene 60 mg x 2 taken orally daily
  • Usual Approach Group (Generic-1)
Drug: Raloxifene - Usual
  • Generic-1 - raloxifene hydrochloride tablet
  • Raloxifene 60 mg x 2 taken orally daily
Other Names:
  • Raloxifene Chemotherapy (Generic-1)
Experimental: Raloxifene - Study
  • Generic-2 - Raloxifene
  • Chemotherapy
  • Generic-2 - Raloxifene Hydrochloride Tablet
  • Raloxifene 60 mg x 2 taken orally daily
  • Usual Approach Group (Generic-2)
Drug: Raloxifene - Study
  • Generic-2 - Raloxifene Hydrochloride Tablet
  • Raloxifene 60 mg x 2 taken orally daily
Other Names:
  • Raloxifene Chemotherapy (Generic-2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure and Report Raloxifene oncology drug target ER SNP Genotypes which are effectiveness associated.
Time Frame: 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.
Up to 12 weeks
Measure and Report Raloxifene oncology drug target UGT SNP Genotypes which are risk associated.
Time Frame: 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.
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Study Chair: Han Xu, MD/PhD/FAPCR, Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
  • Study Director: Han Xu, MD/PhD/FAPCR, Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
  • Principal Investigator: Han Xu, MD/PhD/FAPCR, Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2025

Primary Completion (Estimated)

December 18, 2026

Study Completion (Estimated)

December 28, 2026

Study Registration Dates

First Submitted

September 9, 2023

First Submitted That Met QC Criteria

September 25, 2023

First Posted (Actual)

October 2, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 18, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANDA 220176 (Registry Identifier: FDA, ANDA)
  • FWA00015357 (Registry Identifier: HHS, Human Protections Administrator)
  • IORG0007849 (Registry Identifier: HHS, IORG)
  • IRB00009424 (Registry Identifier: HHS, IRB)
  • NPI - 1831468511 (Registry Identifier: HHS, Health Care Provider Individual)
  • NPI - 1023387701 (Registry Identifier: HHS, Health Care Provider Organization)
  • IND 178166 (Registry Identifier: FDA, IND Commercial)
  • MD-SDAT - D11379922 (Registry Identifier: STATE OF MARYLAND, HMO)
  • DUNS - 832463090 (Registry Identifier: FDA, Clinical Bioequivalence Study)
  • FEI - 3012018761 (Registry Identifier: FDA, Clinical Bioequivalence Study)
  • Labeler - 69891 (Registry Identifier: FDA, Clinical Bioequivalence Study)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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