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Trial Title:
Impact of Immuno-Oncologic Agent on Neoadjuvant Chemotherapy in Triple Negative Breast Cancer
NCT ID:
NCT05910710
Condition:
Triple Negative Breast Cancer
Neoadjuvant Chemotherapy
Pembrolizumab
Tumor Microenvironment
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Genetic
Intervention name:
Visium, Whole Genome Sequencing(WGS)/Whole Transcriptome Sequencing(WTS)
Description:
Visium : Spatial transcriptomics WGS/WTS : detection of somatic mutation
Arm group label:
Subjects administered Neoadjuvant Pembrolizumab
Arm group label:
Subjects not administered Neoadjuvant Pembrolizumab
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)
Criteria for eligibility:
Study pop:
Locally advanced triple negative breast cancer subjects who were administered neoadjuvant
chemotherapy with Weekly paclitaxel, Carboplatin followed by Doxorubicin,
Cyclophosphamide add Pembrolizumab or not
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Yeon Hee Park, MD, Ph.D
Phone:
82-2-3410-1780
Email:
yeonh.park@samsung.com
Start date:
March 2, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Samsung Medical Center
Agency class:
Other
Source:
Samsung Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05910710
