Bioequivalence ANDA SNP Clinical Study - Raloxifene and Single Nucleotide Polymorphisms

Phase 3Active Not RecruitingNCT06062810

Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair600 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Conditions

Breast Cancer

Interventions

Raloxifene - UsualDRUG

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

Raloxifene - StudyDRUG

* Generic-2 - Raloxifene tablet * Raloxifene 60 mg taken orally daily

Eligibility

Sex: FEMALEMin age: 24 YearsMax age: 64 Years

Medical Language ↔ Plain English

* 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

Locations (1)

Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

Rockville, Maryland, United States

Outcomes

Primary Outcomes

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 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 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.

Time frame: 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 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 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.

Time frame: Up to 12 weeks

Data from ClinicalTrials.gov

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