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| ID | Type | Description | Link |
|---|---|---|---|
| FWA00015357 | Registry Identifier | HHS, Human Protections Administrator | |
| IRB00009424 | Registry Identifier | HHS, IRB | |
| IORG0007849 | Registry Identifier | HHS, IORG | |
| NPI - 1831468511 | Registry Identifier | HHS, Health Care Provider Individual | |
| NPI - 1023387701 | Registry Identifier | HHS, Health Care Provider Organization | |
| ANDA 220176 | Registry Identifier | FDA, ANDA | |
| IND 178166 | Registry Identifier | FDA, IND Commercial | |
| MD-SDAT - D11379922 | Registry Identifier | STATE OF MARYLAND, HMO | |
| DUNS - 832463090 | Registry Identifier | FDA, Clinical Bioequivalence Study | |
| FEI - 3012018761 | Registry Identifier | FDA, Clinical Bioequivalence Study | |
| Labeler - 69891 | Registry Identifier | FDA, Clinical Bioequivalence Study |
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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.
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 x 2 daily, it will try to look for the relationship between the Raloxifene therapeutic efficacy and the ER SNP Genotyping, after blood draw, to look for the relationship between the Raloxifene therapeutic safety and the UGT SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.
The study approach group, after breast tissue biopsy, 300 double blind random group separated BC-LCIS patients currently used the Chemotherapy on Generic-2 - Raloxifene Hydrochloride Tablet, 60 mg x 2 daily, it will try to look for the relationship between the Raloxifene therapeutic efficacy and the ER SNP Genotyping, after blood draw, to look for the relationship between the Raloxifene therapeutic safety and the UGT SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Raloxifene - Usual | Experimental |
|
|
| Raloxifene - Study | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raloxifene - Usual | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure and Report Raloxifene oncology drug target ER SNP Genotypes which are effectiveness associated. |
| Up to 12 weeks |
| Measure and Report Raloxifene oncology drug target UGT SNP Genotypes which are risk associated. |
| Up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Postmenopausal Women
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| Name | Affiliation | Role |
|---|---|---|
| Han Xu, MD/PhD/FAPCR | Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701 | Study Chair |
| Han Xu, MD/PhD/FAPCR | Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701 | Study Director |
| Han Xu, MD/PhD/FAPCR | Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701 | Rockville | Maryland | 20853 | United States |
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| Label | URL |
|---|---|
| FWA \< 00015357 \> \< Medicine Invention Design Incorporation (MIDI) \> | View source |
| IRB \< 00009424 \> \< Medicine Invention Design Incorporation (MIDI) \> | View source |
| IORG \< 0007849 \> \< Medicine Invention Design Incorporation (MIDI) \> |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 30, 2026 | Apr 17, 2026 | Prot_013.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 30, 2026 | Apr 17, 2026 | SAP_014.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 30, 2026 | Apr 17, 2026 | ICF_015.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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No-placebo and random and double blind
| Raloxifene - Study | Drug |
|
|
|
| View source |
| D017437 |
| Skin and Connective Tissue Diseases |