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AzTrials

Breast CancerPhase 2/3Drugs-SNPsNCT06062810

Bioequivalence ANDA SNP Clinical Study - Raloxifene and Single Nucleotide Polymorphisms

A Phase 2/3 study testing Raloxifene - Usual and Raloxifene - Study in people with Breast Cancer, run by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 24 to 64 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Raloxifene - Usual and Raloxifene - Study
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteUnited States
Study dates
21 Jun 2025to 28 Dec 2026
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 to 64 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 10Show fewer
  • Adequate performance status
  • Age 22 years old and over
  • Sign an informed consent form
  • Receive blood-drawing

Who cannot join

  • 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
Show all 12Show fewer
  • Serious Allergy to Drugs
  • Thrombus or Bleed Tendency
  • Serious Risks or Serious Adverse Events of the drug product
  • The prohibition of drug products
  • Have no therapeutic effects
  • Follow up to the most current label

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

    Rockville, Maryland, 20853

Other trials in United States

About this study

Official title: Explore the Relationship Between Single Nucleotide Polymorphisms and Raloxifene Response and Toxicity in Patients With Breast Cancer LCIS

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.

Read the detailed description

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.

  1. Detect drug target whole gene precision sequence of everyone patient for all 600 recruited double-blind BC-LCIS patients.
  2. Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double-blind BC-LCIS patients.
  3. Calculate drug target gene SNPs in all 600 recruited double-blind BC-LCIS patients.
  4. Correlate everyone patient drug target gene SNP to everyone patient drug efficacy.
  5. Correlate everyone patient drug target gene SNP to everyone patient drug safety.
  6. Mutually compare the usual approach group SNPs (300 double blind random group separated BC-LCIS patients) with the study approach group SNPs (300 double blind random group separated BC-LCIS patients).
  7. Confirm the relationship between drug target gene SNPs and drug efficacy.
  8. Confirm the relationship between drug target gene SNPs and drug safety.
Conditions
Breast Cancer
Being tested
Raloxifene - Usual, Raloxifene - Study
Keywords
LCIS, ER, UGT, SNP, Pharmacogenomics, Gene, Genetics
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Raloxifene - UsualDrug

    Also called Raloxifene Chemotherapy (Generic-1)

    • Generic-1 - raloxifene hydrochloride tablet
    • Raloxifene 60 mg x 2 taken orally daily

  • Raloxifene - StudyDrug

    Also called Raloxifene Chemotherapy (Generic-2)

    • Generic-2 - Raloxifene Hydrochloride Tablet
    • Raloxifene 60 mg x 2 taken orally daily
Study groups in NCT06062810
Study groupRoleWhat they receive
Raloxifene - UsualExperimental* Generic-1 - Raloxifene * Chemotherapy * Generic-1 - raloxifene hydrochloride tablet * Raloxifene 60 mg x 2 taken orally daily * Usual Approach Group (Generic-1)
Receives: Drug: Raloxifene - Usual
Raloxifene - StudyExperimental* Generic-2 - Raloxifene * Chemotherapy * Generic-2 - Raloxifene Hydrochloride Tablet * Raloxifene 60 mg x 2 taken orally daily * Usual Approach Group (Generic-2)
Receives: Drug: Raloxifene - Study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 12 weeks

  2. 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.

    Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2023
  2. Study start21 Jun 2025
  3. Primary completion18 Dec 2026 (estimated)
  4. Study completion28 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
* The usual approach group (Generic-1) * The study approach group (Generic-2)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06062810
Sponsor's protocol ID
ANDA 220176
Other IDs
FWA00015357, IRB00009424, IORG0007849, NPI - 1831468511, NPI - 1023387701, ANDA 220176, IND 178166, MD-SDAT - D11379922
Acronym
Drugs-SNPs
Status last verified
Apr 2026
First submitted
9 Sep 2023
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Raloxifene - Usual and Raloxifene - Study in people with Breast Cancer, run by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measure and Report Raloxifene oncology drug target ER SNP Genotypes which are effectiveness associated. (time frame: Up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06062810.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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