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

Summary

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: Homo sapiens

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 (< 45 years), large size (>
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

Data
access

The data generated
and analysed in the related studyare openly available as part of this figshare 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.

Corresponding author(s) for this study

Michael
J. Campbell PhD, Department of Surgery, University of California- San
Francisco, 2330 Sutter St, N321, San Francisco CA 94115. [e-mail].

Study approval

This
study was approved by the Institutional Review Board of the University of
California, San Francisco, and all patients signed written informed consent.