Bioequivalence ANDA SNP Clinical Study - Raloxifene and Single Nucleotide Polymorphisms

NCT06062810 | Active Not Recruiting Phase 2 DMC FDA Drug

• 11 other identifiers: ANDA 220176FWA00015357IRB00009424IORG0007849NPI - 1831468511NPI - 1023387701IND 178166MD-SDAT - D11379922DUNS - 832463090FEI - 3012018761Labeler - 69891
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

LCIS; ER; UGT; SNP; Pharmacogenomics; Gene; Genetics

Outcome Measures

Primary Outcomes (2)

• Measure and Report Raloxifene oncology drug target ER SNP Genotypes which are effectiveness associated.

  * 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.

  * 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

Study Arms (2)

Raloxifene - Usual

EXPERIMENTAL

* 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

Raloxifene - Study

EXPERIMENTAL

* 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

Interventions

Raloxifene - Usual DRUG

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

Also known as: Raloxifene Chemotherapy (Generic-1)

Raloxifene - Usual

Raloxifene - Study DRUG

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

Also known as: Raloxifene Chemotherapy (Generic-2)

Raloxifene - Study

Eligibility Criteria

• Age: 24 Years - 64 Years
• Gender Eligibility Details: Postmenopausal Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of Breast Cancer LCIS
• Clinical breast tissue biopsy diagnosis showing lobular carcinoma in situ (LCIS)
• Suitable for enough breast tissue biopsy of Breast Cancer LCIS
• Random and double blind
• Measurable disease
• Adequate organ functions
• Adequate performance status
• Age 22 years old and over
• Sign an informed consent form
• Receive blood-drawing

You may not qualify if:

• Mastectomy
• Treatment with other anti-cancer therapies and cannot be stopped currently
• Pregnancy
• Breast-feeding
• The patients with other serious intercurrent illness or infectious diseases
• Have more than one different kind of cancer at the same time
• Serious Allergy to Drugs
• Thrombus or Bleed Tendency
• Serious Risks or Serious Adverse Events of the drug product
• The prohibition of drug products
• Have no therapeutic effects
• Follow up to the most current label

Sponsors & Collaborators

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

Study Sites (1)

Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

Rockville, Maryland, 20853, United States

Location

Related Links

• FWA \< 00015357 \> \< Medicine Invention Design Incorporation (MIDI) \>
• IRB \< 00009424 \> \< Medicine Invention Design Incorporation (MIDI) \>
• IORG \< 0007849 \> \< Medicine Invention Design Incorporation (MIDI) \>

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Han Xu, MD/PhD/FAPCR

  Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

  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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: No-placebo and random and double blind
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Ph.D., FAPCR, Sponsor-Investigator, Medical Director, Medical Monitor, Safety Officer, IORG Director, IRB Chair

Model Details: * The usual approach group (Generic-1) * The study approach group (Generic-2)

Study Record Dates

• First Submitted: September 9, 2023
• First Posted: October 2, 2023
• Study Start: June 21, 2025
• Primary Completion (Estimated): December 18, 2026
• Study Completion (Estimated): December 28, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)