Status:
ACTIVE_NOT_RECRUITING
Pharmacogenomics ANDA SNP Clinical Study - Raloxifene and Single Nucleotide Polymorphisms
Lead Sponsor:
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Conditions:
Breast Cancer
Eligibility:
FEMALE
24-64 years
Phase:
PHASE2
PHASE3
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 t...
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 dai...
Eligibility Criteria
Inclusion
- 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.
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 28 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06062810
Start Date
June 21 2025
End Date
December 28 2026
Last Update
July 10 2025
Active Locations (1)
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1
Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
Rockville, Maryland, United States, 20853