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

Conditions

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

Study Contact Backup

Study Locations

  • Korea, Republic of
      • 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
Procedure: LAG-3 expression / immune checkpoint protein expression
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

Samsung Medical Center

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.

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