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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05910710
Enrollment
50
Registered
2023-06-20
Start date
2023-03-02
Completion date
2025-12-31
Last updated
2023-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoadjuvant Chemotherapy, Pembrolizumab, Triple Negative Breast Cancer, Tumor Microenvironment

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)

Interventions

GENETICVisium, Whole Genome Sequencing(WGS)/Whole Transcriptome Sequencing(WTS)

Visium : Spatial transcriptomics WGS/WTS : detection of somatic mutation

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Genomic profiling will be assessed by tissue and blood samples(analyze the TME changes)3yearTissue and blood will be tested for Spatial transcriptomics, WGS(Wilcoxon rank sum test or Chi-square test, cell-cell interaction)

Countries

South Korea

Contacts

Primary ContactYeon Hee Park, MD, Ph.D
yeonh.park@samsung.com82-2-3410-1780

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026