- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05910710
Impact of Immuno-Oncologic Agent on Neoadjuvant Chemotherapy in Triple Negative Breast Cancer
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)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yeon Hee Park, MD, Ph.D
- Phone Number: 82-2-3410-1780
- Email: yeonh.park@samsung.com
Study Locations
-
-
-
Seoul, Korea, Republic of, 06351
- Recruiting
- Samsung Medical Center
-
Contact:
- Yeon Hee Park, MD, Ph.D
- Phone Number: 82-2-3410-1780
- Email: yeonh.park@samsung.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Subjects administered Neoadjuvant Pembrolizumab
Neoadjuvant Weekly paclitaxel, Carboplatin followed by Doxorubicin, Cyclophosphamide add Pembrolizumab
|
Visium : Spatial transcriptomics WGS/WTS : detection of somatic mutation
|
Subjects not administered Neoadjuvant Pembrolizumab
Neoadjuvant Weekly paclitaxel, Carboplatin followed by Doxorubicin, Cyclophosphamide
|
Visium : Spatial transcriptomics WGS/WTS : detection of somatic mutation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
3year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-02-019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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