Triple Negative Breast CancerNCT06259162
LAG3 Expression in Triple Negative Breast Cancer
A study testing LAG-3 expression / immune checkpoint protein expression in people with Triple Negative Breast Cancer and Immune Checkpoint Inhibitor, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study is the experimental study for relationship between LAG-3 expression / immue checkpoint protein expression and neoadjuvant chemotherapy plus immune checkpoint inhibitor in triple negative breast cancer. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Triple Negative Breast Cancer, Immune Checkpoint Inhibitor
- What is being tested?
- LAG-3 expression / immune checkpoint protein expression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Nov 2022to 31 Dec 2027
- Phase
- Interventional
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Planned neoadjuvant chemotherapy
- Triple negative breast cancer
Who cannot join
- HER2-positive breast cancer
- Hormone receptor positive breast cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Ji-Yeon Kim
Seoul, 06351
Ji-Yeon Kim
About this study
Official title: The Evaluation the Relationship Between LAG-3 Expression / Immune Checkpoint Protein Expression and Neoadjuvant Chemotherapy Plus Immune Checkpoint Inhibitor in Triple Negative Breast Cancer
This study is the experimental study for relationship between LAG-3 expression / immue checkpoint protein expression and neoadjuvant chemotherapy plus immune checkpoint inhibitor in triple negative breast cancer.
- Being tested
- LAG-3 expression / immune checkpoint protein expression
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAG-3 expression / immune checkpoint protein expressionProcedure or surgery
Evaluate the tissue and blood before and after chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| LAG-3 expression/immune checkpoint protein expression evaluation | Experimental | Not described Receives: Procedure: LAG-3 expression / immune checkpoint protein expression |
What is being measured
The primary outcome is the main question the study is designed to answer.
LAG-3 expression/immune checkpoint preotein expression
Relationship neoadjuvant chemotherapy plus immune checkpoint inhibitor
Measured: Before chemotherapy, 1 weeks & 3 weeks after chemotherapy, curative surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start18 Nov 2022
- Primary completion1 Jul 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JI-YEON, KIM, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259162
- Sponsor's protocol ID
- LAG3_Breast
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation the Relationship Between LAG-3 Expression / Immune Checkpoint Protein Expression and Neoadjuvant Chemotherapy Plus Immune Checkpoint Inhibitor in Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06259162
- Acronym / sponsor ID
- LAG3_Breast
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is the experimental study for relationship between LAG-3 expression / immue checkpoint protein expression and neoadjuvant chemotherapy plus immune checkpoint inhibitor in triple negative breast cancer.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LAG-3 expression/immune checkpoint protein expression evaluation | Experimental | Procedure: LAG-3 expression / immune checkpoint protein expression |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Planned neoadjuvant chemotherapy
- Triple negative breast cancer
Key exclusion criteria (2 listed)
- HER2-positive breast cancer
- Hormone receptor positive breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAG-3 expression / immune checkpoint protein expressionEvaluate the tissue and blood before and after chemotherapy | Procedure or surgery | LAG-3 expression/immune checkpoint protein expression evaluation |
Primary outcome
LAG-3 expression/immune checkpoint preotein expression
Time frame: Before chemotherapy, 1 weeks & 3 weeks after chemotherapy, curative surgery
Relationship neoadjuvant chemotherapy plus immune checkpoint inhibitor
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LAG-3 expression / immune checkpoint protein expression in people with Triple Negative Breast Cancer and Immune Checkpoint Inhibitor, run by Samsung Medical Center at 1 site in South Korea.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 14 Feb 2024. 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 South Korea. 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.
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?
Contact Ji-Yeon Kim (82-2-3410-3459, jyeon25@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LAG-3 expression/immune checkpoint preotein expression (time frame: Before chemotherapy, 1 weeks & 3 weeks after chemotherapy, curative surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2024.