Pembrolizumab and Paclitaxel in Hypermutated Breast Cancer

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 plus Paclitaxel Number of trial subjects: 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 48 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