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

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

Timeline

Start

2021-07

Primary completion

2022-12

Completion

2022-12

Drugs

Indications