Active — Not RecruitingPhase 2/3

Bioequivalence ANDA SNP Clinical Study - Raloxifene and Single Nucleotide Polymorphisms

United States600 participantsStarted 2025-06-21

Plain-language 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 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.

Who can participate

Age range24 Years – 64 Years

SexFEMALE

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Measure and Report Raloxifene oncology drug target ER SNP Genotypes which are effectiveness associated.

Timeframe: Up to 12 weeks

Measure and Report Raloxifene oncology drug target UGT SNP Genotypes which are risk associated.

Timeframe: Up to 12 weeks

Trial details

NCT IDNCT06062810

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

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-18

View on ClinicalTrials.gov More Breast Cancer trials