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

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

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Raloxifene - Study; Drug: Raloxifene - Usual

Study type: Interventional

Funder types: Industry

Identifiers

NCT06062810

IRB00009424 (Registry Identifier)

FWA00015357 (Registry Identifier)

NPI - 1023387701 (Registry Identifier)

NPI - 1831468511 (Registry Identifier)

IORG0007849 (Registry Identifier)

ANDA 220176 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 24 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups

Raloxifene - Usual

Experimental group

Description:

* Generic-1 - Raloxifene * Chemotherapy * Generic-1 - raloxifene hydrochloride tablet * Raloxifene 60 mg taken orally daily * Usual Approach Group (Generic-1)

Treatment:

Drug: Raloxifene - Usual

Raloxifene - Study

Experimental group

Description:

* Generic-2 - Raloxifene * Chemotherapy * Generic-2 - Raloxifene tablet * Raloxifene 60 mg taken orally daily * Usual Approach Group (Generic-2)

Treatment:

Drug: Raloxifene - Study