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Pembrolizumab in Combination With Paclitaxel in the Hormone Receptor-positive Metastatic Breast Cancer With High Tumor Mutational Burden Selected by Whole Exome Sequencing: Korean Cancer Study Group Trial (KCSG BR20-16)

Metastatic Breast Cancer Clinical Trial

Official title:
Phase II Trial of Pembrolizumab in Combination With Paclitaxel in the Hormone Receptor-positive Metastatic Breast Cancer With High Tumor Mutational Burden Selected by Whole Exome Sequencing: Korean Cancer Study Group Trial (KCSG BR20-16)

Clinical Trial Summary

Abbreviated Title : Pembrolizumab in hypermutated breast cancer Trial Phase : II Clinical Indication : Hormone receptor-positive metastatic breast cancer Trial Type : Interventional Type of control : None Route of administration : Intravenous Trial Blinding : None Treatment Groups : Pembrolizumab Number of trial subjects : Approximately 150 patients will be prescreened with whole exome sequencing. Then 30 patients will be enrolled in the treatment phase. Estimated enrollment period : 12 months Estimated duration of trial : The sponsor estimates that the trial will require approximately 24 months from the time the first subject signs the informed consent until the last subject's last visit. Duration of Participation : 12 months Estimated average length of treatment per patient : 8 months

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03492918
Study type Interventional
Source Yonsei University
Contact
Status Not yet recruiting
Phase Phase 2
Start date April 2022
Completion date May 2023
View Details
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