Metadata record for the manuscript: Nivolumab in combination with cabozantinib for metastatic triple-negative breast cancer: A phase II and biomarker study

<b>Summary</b><br>

This
metadata record provides details of the data supporting the claims of the
related manuscript: “Nivolumab in combination with
cabozantinib for metastatic triple-negative breast cancer: A phase II and
biomarker study”.

The
related study was a single-arm phase II study which investigated the efficacy
and safety of cabozantinib combined with nivolumab in metastatic
triple-negative breast cancer (mTNBC).

Type of data:
whole exome sequencing; linked genotype and phenotype data; genomic profiling; open-label,
single-arm, single center phase II study; clinical data

Subject of
data: <i>Homo sapiens</i>

Sample size:
18

Population
characteristics: Eligible patients had histologically or cytologically
confirmed invasive breast cancer with metastatic disease that was measurable
per RECIST 1.1 . Tumors were required to be estrogen receptor (ER)-negative and
progesterone receptor-negative, defined as &lt; 10% expression by
immunohistochemistry, and HER2-negative per the current American Society of
Clinical Oncology/College of American Pathologists guidelines

Trial
registration number: NCT03316586

<b>Data
access</b>

The whole
exome and transcriptome data have been deposited in the <i>dbGaP </i>repository under accession https://identifiers.org/dbgap:phs002419.v1.p1. In order to protect patient privacy, these data are controlled access.
Details of how to request access can be found on the <i>dbGaP </i>landing page.

The genomic
profiling data are in Supplementary Tables 2 and 4.

The supplementary
tables of the related article are openly available as part of this <i>figshare </i>data record (as well as via the
supplementary materials of the related article) in the file ‘Supplementary Data 1_5-14-21.xlsx’.

<b>Corresponding author(s) for this study</b>

Sara
M. Tolaney, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA
02215. Tel: [phone]. [e-mail]

<br>
<b>Study approval </b>

The
Dana-Farber Cancer Institute institutional review board approved the study and
written informed consent from all trial participants was provided before study
entry. The study was monitored by the Data Safety Monitoring Board of the
Dana-Farber/Harvard Cancer Center.