NCT04946227

Pembrolizumab and Paclitaxel in Hormone Receptor-positive, hyperMUTATted Metastatic Breast Cancer Identified by Whole exOme sequeNcing ('MUTATION2')

Phase II Trial of Pembrolizumab and Paclitaxel in Hormone Receptor-positive, hyperMUTATted Metastatic Breast Cancer Identified by Whole exOme sequeNcing ('MUTATION2')

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Abbreviated Title :Pembrolizumab with paclitaxel in hypermutated breast cancer Trial Phase: 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 plus paclitaxel Number of trial participants: Approximately 200 patients will be prescreened with whole exome sequencing. Then 52 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 :24 months Estimated average length of treatment per patient :8 months

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab 200mg +Paclitaxel 80mg/m2	Pembrolizumab 200mg +Paclitaxel 80mg/m2

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2021-06-30
• Last updated: 2021-06-30

Locations

1 site across 1 country: South Korea