A Phase 2/3 interventional study of Raloxifene - Usual and Raloxifene - Study in Breast Cancer, sponsored by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair. Active, not recruiting at 1 site in United States. Open to female participants aged 24 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair · Phase 2/3, Interventional, and Health services research
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 600 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* Generic-1 - Raloxifene * Chemotherapy * Generic-1 - raloxifene hydrochloride tablet * Raloxifene 60 mg x 2 taken orally daily * Usual Approach Group (Generic-1)
Drug: Raloxifene - Usual
* Generic-2 - Raloxifene * Chemotherapy * Generic-2 - Raloxifene Hydrochloride Tablet * Raloxifene 60 mg x 2 taken orally daily * Usual Approach Group (Generic-2)
Drug: Raloxifene - Study
* Generic-1 - raloxifene hydrochloride tablet * Raloxifene 60 mg x 2 taken orally daily
Also known as: Raloxifene Chemotherapy (Generic-1)
* Generic-2 - Raloxifene Hydrochloride Tablet * Raloxifene 60 mg x 2 taken orally daily
Also known as: Raloxifene Chemotherapy (Generic-2)
Measure and Report Raloxifene oncology drug target ER SNP Genotypes which are effectiveness associated.
* 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.
Time frame: Up to 12 weeks
Measure and Report Raloxifene oncology drug target UGT SNP Genotypes which are risk associated.
* 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.
Time frame: Up to 12 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair