Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06062810 | Bioequivalence ANDA SNP Clinical Study - Raloxifene and Single Nucleotide Polymorphisms | PHASE2 | ACTIVE NOT_RECRUITING | 600 | — | — | Jun 21, 2025 | Dec 28, 2026 | Apr 23, 2026 | 1 | United States |
* Recruit 300 double blind random group separated Breast Cancer LCIS patients currently using the Chemotherapy dose on Generic-1 - raloxifene (60mg x 2 orally daily), after breast tissue biopsy, to be the usual approach group. * Recruit 300 double blind random group separated Breast Cancer LCIS patients currently using the Chemotherapy dose on Generic-2 - raloxifene (60mg x 2 orally daily), after breast tissue biopsy, to be the study approach group. * Measure above every BC-LCIS patient specific Raloxifene oncology drug target ER SNP genotype in Breast Cancer cell whole genome DNA with Oxford precisely sequencing. * Report every BC-LCIS patient specific ER SNP genotype in whole genome DNA sequence.
* Recruit 300 double blind random group separated Breast Cancer LCIS patients currently using the Chemotherapy dose on Generic-1 - raloxifene (60mg x 2 orally daily), after blood draw, to be the usual approach group. * Recruit 300 double blind random group separated Breast Cancer LCIS patients currently using the Chemotherapy dose on Generic-2 - raloxifene (60mg x 2 orally daily), after blood draw, to be the study approach group. * Measure above every BC-LCIS patient specific Raloxifene oncology drug target UGT SNP genotype in WBC cell whole genome DNA with Oxford precisely sequencing. * Report every BC-LCIS patient specific UGT SNP genotype in whole genome DNA sequence.
| Arm | Type | Description |
|---|---|---|
| Raloxifene - Usual | EXPERIMENTAL | * Generic-1 - Raloxifene * Chemotherapy * Generic-1 - raloxifene hydrochloride tablet * Raloxifene 60 mg x 2 taken orally daily * Usual Approach Group (Generic-1) |
| Raloxifene - Study | EXPERIMENTAL | * Generic-2 - Raloxifene * Chemotherapy * Generic-2 - Raloxifene Hydrochloride Tablet * Raloxifene 60 mg x 2 taken orally daily * Usual Approach Group (Generic-2) |
| Name | Type | Description |
|---|---|---|
| Raloxifene - Usual | DRUG | * Generic-1 - raloxifene hydrochloride tablet * Raloxifene 60 mg x 2 taken orally daily |
| Raloxifene - Study | DRUG | * Generic-2 - Raloxifene Hydrochloride Tablet * Raloxifene 60 mg x 2 taken orally daily |
* 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 sepa...