- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06259162
LAG3 Expression in Triple Negative Breast Cancer
February 6, 2024 updated by: JI-YEON, KIM, Samsung Medical Center
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
128
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ji-Yeon Kim
- Phone Number: 82-2-3410-3459
- Email: jyeon25@skku.edu
Study Contact Backup
- Name: Mee Ryung Hong
- Phone Number: 82-2-2148-7147
- Email: ring7629@naver.com
Study Locations
-
-
-
Seoul, Korea, Republic of, 06351
- Recruiting
- Ji-Yeon Kim
-
Contact:
- Ji-Yeon Kim
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Planned neoadjuvant chemotherapy
- Triple negative breast cancer
Exclusion Criteria:
- HER2-positive breast cancer
- Hormone receptor positive breast cancer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LAG-3 expression/immune checkpoint protein expression evaluation
|
Evaluate the tissue and blood before and after chemotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Before chemotherapy, 1 weeks & 3 weeks after chemotherapy, curative surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 18, 2022
Primary Completion (Estimated)
July 1, 2025
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
February 6, 2024
First Submitted That Met QC Criteria
February 6, 2024
First Posted (Estimated)
February 14, 2024
Study Record Updates
Last Update Posted (Estimated)
February 14, 2024
Last Update Submitted That Met QC Criteria
February 6, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LAG3_Breast
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Triple Negative Breast Cancer
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Peregrine PharmaceuticalsWithdrawnBreast Cancer | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | Triple-Negative Breast Cancer | Triple-Negative Breast Neoplasm | ER-Negative PR-Negative HER2-Negative Breast Neoplasms | ER-Negative PR-Negative HER2-Negative Breast Cancer
-
Washington University School of MedicineNational Cancer Institute (NCI); National Institutes of Health (NIH); MedImmune...TerminatedTriple Negative Breast Cancer | Triple Negative Breast Neoplasms | TNBC - Triple-Negative Breast Cancer | Triple-negative Breast CarcinomaUnited States
-
Swiss Group for Clinical Cancer ResearchNot yet recruitingTriple-negative Breast Cancer | TNBC - Triple-Negative Breast CancerSwitzerland
-
G1 Therapeutics, Inc.TerminatedBreast Cancer | Breast Neoplasm | Triple-Negative Breast Cancer | Triple-Negative Breast NeoplasmsUnited States, Bulgaria, Croatia, Slovenia, Serbia, Belgium, North Macedonia, Slovakia
-
AkesoRecruitingMetastatic Triple-negative Breast Cancer | Locally Advanced Triple-negative Breast CancerChina
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
Fudan UniversityNot yet recruitingTriple-negative Breast Cancer
-
Fudan UniversityRecruitingTriple-Negative Breast CancerChina
-
Fudan UniversityRecruiting
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Fudan UniversityRecruiting
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