Bioequivalence ANDA SNP Clinical Study - Raloxifene and Single Nucleotide Polymorphisms
Running, not enrolling · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT06062810
- Run by
- Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
- People needed
- 600
- Starts
- 2025-06-21
- Expected to finish
- 2026-12-28
- Last updated by the study team
- 2026-04-23
Who can join
Age: 24 and older, up to 64. Sex: female. Healthy volunteers: not accepted.
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
Where it is running
- Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701 — Rockville, Maryland, United States
Full record on ClinicalTrials.gov
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