Clinical trial · Interventional
Bioequivalence ANDA SNP Clinical Study - Raloxifene and Single Nucleotide Polymorphisms
Explore the Relationship Between Single Nucleotide Polymorphisms and Raloxifene Response and Toxicity in Patients With Breast Cancer LCIS
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Raloxifene - Study | Drug | — | UNRESOLVED |
| Raloxifene - Usual | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Raloxifene - Usual
- description
- * Generic-1 - Raloxifene * Chemotherapy * Generic-1 - raloxifene hydrochloride tablet * Raloxifene 60 mg x 2 taken orally daily * Usual Approach Group (Generic-1)
- interventionNames
- Drug: Raloxifene - Usual
- type
- EXPERIMENTAL
- label
- Raloxifene - Study
- description
- * Generic-2 - Raloxifene * Chemotherapy * Generic-2 - Raloxifene Hydrochloride Tablet * Raloxifene 60 mg x 2 taken orally daily * Usual Approach Group (Generic-2)
- interventionNames
- Drug: Raloxifene - Study
Primary outcomes (2)
- measure
- Measure and Report Raloxifene oncology drug target ER SNP Genotypes which are effectiveness associated.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 24 Years
- Maximum age
- 64 Years
Show eligibility criteria text
* 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
References
Publications (0)
Data not yet available