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Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 13, 2026
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Phase 2 Trial.
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Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT03492918). This is a study registration, not published results. Lead sponsor: Yonsei University. Recruitment status: COMPLETED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 52 participants (ACTUAL). Conditions: Breast Neoplasms. Interventions: DRUG: Pembrolizumab, paclitaxel. Primary outcome measures: Investigator-assessed objective response rate (ORR) , Tumour assessment was performed at baseline and every 8 weeks (+/- 7 days) based on appropriate imaging studies, such as computed tomography (CT) scans or magnetic resonance imaging (MRI) scans until progressive disease based on RECIST criteria version 1. Brief 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 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