Pharmacogenomics ANDA SNP Clinical Study - Raloxifene and Single Nucleotide Polymorphisms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-21

Study Completion Date

2026-12-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

No-placebo and random and double blind

Study Groups

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Raloxifene - Usual

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

Group Type EXPERIMENTAL

Raloxifene - Usual

Intervention Type DRUG

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

Raloxifene - Study

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

Group Type EXPERIMENTAL

Raloxifene - Study

Intervention Type DRUG

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

Interventions

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Raloxifene - Usual

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

Intervention Type DRUG

Raloxifene - Study

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

Intervention Type DRUG

Other Intervention Names

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Raloxifene Chemotherapy (Generic-1) Raloxifene Chemotherapy (Generic-2)

Eligibility Criteria

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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

Minimum Eligible Age

24 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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

M.D., Ph.D., FAPCR, Sponsor-Investigator, Medical Director, Medical Monitor, Safety Officer, IORG Director, IRB Chair

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Han Xu, MD/PhD/FAPCR

Role: STUDY_CHAIR

Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

Han Xu, MD/PhD/FAPCR

Role: STUDY_DIRECTOR

Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

Han Xu, MD/PhD/FAPCR

Role: PRINCIPAL_INVESTIGATOR

Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

Locations

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Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

Rockville, Maryland, United States

Site Status

Countries

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United States

Provided Documents

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