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
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