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

• Status: Not yet recruiting
• Trial end date: 2022-12-01

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

• Phase: Phase 2

Details

• Lead Sponsor: Yonsei University
• Treatments: Paclitaxel; Pembrolizumab