NCT03492918

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)

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)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Trial treatment should be administered on Day 1 of each cycle after all procedures/assessments have been completed as detailed on the Trial Flow Chart. Trial treatment may be administered up to 3 days before or after the scheduled Day 1 of each cycle due to administrative reasons. All trial treatments will be administered on an outpatient basis. Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Sites should make every effort to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-04-01
• Completion: 2023-05-01
• First posted: 2018-04-10
• Last updated: 2022-03-15

Locations

1 site across 1 country: South Korea