Metadata record for the manuscript: Modulation of the immune microenvironment of high-risk breast ductal carcinoma in situ by intralesional injection of pembrolizumab

<b>Summary</b><br> This metadata record provides details of the data supporting the claims of the related manuscript: “Modulation of the immune microenvironment of high-risk breast ductal carcinoma in situ by intralesional injection of pembrolizumab”. The primary objective of this trial described in the related study was to establish the safety and feasibility of intralesional immunotherapy in patients with DCIS. A secondary objective was to evaluate changes in the tumour immune microenvironment pre- vs. post-therapy. Exploratory objectives included an evaluation of tumour volume measured using MRI pre- versus post-pembrolizumab therapy as well as an evaluation of markers of apoptosis (cleaved caspase 3) and proliferation (Ki67), pre- versus post-therapy. Type of data: clinical data; immune infiltrates data—Excel spreadsheet format Subject of data: <i>Homo sapiens</i> Sample size: 9 Population characteristics: Patients with pathologically-confirmed breast ductal carcinoma in situ (DCIS) were eligible for enrollment if they possessed at least two of the following high-risk features: young age (&lt; 45 years), large size (&gt; 5cm), high-grade (grade II or III), a palpable mass, hormone receptor (HR) negativity, and/or HER2 positivity. Recruitment: Participants were recruited from the University of California San Francisco (UCSF) Breast Care Center when evaluated by one of the breast surgical oncologists participating in this study. Date of data collection: Patients were recruited between March 2017 and June 2018. Trial registration number: NCT02872025 <b>Data access</b> The data generated and analysed in the related studyare openly available as part of this <i>figshare </i>metadata record in the file ‘Immune Infiltrates Data.xls’. This spreadsheet contains 6 tabs labelled according to the figure of the related article that it underlies. <b>Corresponding author(s) for this study</b> Michael J. Campbell PhD, Department of Surgery, University of California- San Francisco, 2330 Sutter St, N321, San Francisco CA 94115. [e-mail]. <br> <b>Study approval </b> This study was approved by the Institutional Review Board of the University of California, San Francisco, and all patients signed written informed consent.