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Impact of Immuno-Oncologic Agent on Neoadjuvant Chemotherapy in Triple Negative Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05910710
Recruitment Status : Recruiting
First Posted : June 20, 2023
Last Update Posted : June 20, 2023
Sponsor:
Information provided by (Responsible Party):
Yeon Hee Park, Samsung Medical Center

Study Description
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Brief Summary:

It analyzes the Tumor microenvironment(TME) changes in non pathologic complete response(pCR) subjects among subjects who were administered neoadjuvant pembrolizumab and those who were not administered neoadjuvant pembrolizumab for triple negative breast cancer.

(Neoadjuvant Weekly paclitaxel, Carboplatin +- Pembrolizumab followed by Doxorubicin, Cyclophosphamide +- Pembrolizumab regimen)


Condition or disease Intervention/treatment
Triple Negative Breast Cancer Neoadjuvant Chemotherapy Pembrolizumab Tumor Microenvironment Genetic: Visium, Whole Genome Sequencing(WGS)/Whole Transcriptome Sequencing(WTS)

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Impact of Immuno-Oncologic Agent on Neoadjuvant Chemotherapy in Triple Negative Breast Cancer
Actual Study Start Date : March 2, 2023
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
Subjects administered Neoadjuvant Pembrolizumab
Neoadjuvant Weekly paclitaxel, Carboplatin followed by Doxorubicin, Cyclophosphamide add Pembrolizumab
 Genetic: Visium, Whole Genome Sequencing(WGS)/Whole Transcriptome Sequencing(WTS)
Visium : Spatial transcriptomics WGS/WTS : detection of somatic mutation
Subjects not administered Neoadjuvant Pembrolizumab
Neoadjuvant Weekly paclitaxel, Carboplatin followed by Doxorubicin, Cyclophosphamide
 Genetic: Visium, Whole Genome Sequencing(WGS)/Whole Transcriptome Sequencing(WTS)
Visium : Spatial transcriptomics WGS/WTS : detection of somatic mutation


Outcome Measures
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Primary Outcome Measures :
  1. Genomic profiling will be assessed by tissue and blood samples(analyze the TME changes) [ Time Frame: 3year ]
    Tissue and blood will be tested for Spatial transcriptomics, WGS(Wilcoxon rank sum test or Chi-square test, cell-cell interaction)


Biospecimen Retention:   Samples With DNA
Blood : Germline DNA Tissue : DNA/RNA

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Locally advanced triple negative breast cancer subjects who were administered neoadjuvant chemotherapy with Weekly paclitaxel, Carboplatin followed by Doxorubicin, Cyclophosphamide add Pembrolizumab or not
Criteria

Inclusion Criteria:

  • Triple negative breast cancer
  • Subjects administered neoadjuvant Weekly paclitaxel, Carboplatin followed by Doxorubicin, Cyclophosphamide add Pembrolizumab or not
  • Non pCR patients who are undergoing surgery after neoadjuvant chemotherapy
  • Sign to informed consent

Exclusion Criteria:

  • Patients with difficulty in obtaining sufficient samples
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05910710


Contacts
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Contact: Yeon Hee Park, MD, Ph.D 82-2-3410-1780 yeonh.park@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: Yeon Hee Park, MD, Ph.D    82-2-3410-1780    yeonh.park@samsung.com   
Sponsors and Collaborators
Samsung Medical Center
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Yeon Hee Park, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT05910710    
Other Study ID Numbers: 2023-02-019
First Posted: June 20, 2023    Key Record Dates
Last Update Posted: June 20, 2023
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
 Neoplasms
Breast Diseases
Skin Diseases