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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05910710
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 34
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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	Phase
Triple Negative Breast Cancer; Neoadjuvant Chemotherapy; Pembrolizumab; Tumor Microenvironment	Genetic: Visium, Whole Genome Sequencing(WGS)/Whole Transcriptome Sequencing(WTS)

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Impact of Immuno-Oncologic Agent on Neoadjuvant Chemotherapy in Triple Negative Breast Cancer
• Actual Study Start Date: Mar 2, 2023
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	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

Primary Outcome Measures

1. Genomic profiling will be assessed by tissue and blood samples(analyze the TME changes) [3year]

   Tissue and blood will be tested for Spatial transcriptomics, WGS(Wilcoxon rank sum test or Chi-square test, cell-cell interaction)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	06351

Sponsors and Collaborators

• Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yeon Hee Park, Professor, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT05910710
• Other Study ID Numbers: 2023-02-019
• First Posted: Jun 20, 2023
• Last Update Posted: Jun 20, 2023
• Last Verified: Jun 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms

Study Results

No Results Posted as of Jun 20, 2023