Metadata record for the manuscript: Glembatumumab vedotin for patients with metastatic, gpNMB over-expressing, triplenegative breast cancer (“METRIC”): A Randomized Multicenter Study

Summary

This
metadata record provides details of the data supporting the claims of the
related manuscript: “Glembatumumab vedotin for patients with metastatic, gpNMB
over-expressing, triplenegative breast cancer (“METRIC”): A Randomized
Multicenter Study”.

The
related study evaluated whether glembatumumab vedotin (a gpNMB-specific
monoclonal antibody conjugated to the potent cytotoxin monomethyl auristatin E)
would improve progression-free survival compared to capecitabine in
gpNMB-overexpressing triple-negative breast cancer (TNBC).

Data
access

The data are are available from the company which funded the study--Celldex Therapeutics, Inc (https://www.celldex.com/)--on reasonable request for a period of 3 years following publication. After this period Celldex does not commit to making the data available as the compound has been discontinued from development.

The
data, along with details of the figures and tables in the manuscript that they
underlie, are as follows:

Figure 2: CDX011-04_ADEF.sas;
CDX011-04_ADEFI.sas; CDX011-04_ADTTE.sas

Figure 3: CDX011-04_ADEF.sas;
CDX011-04_ADEFI.sas

Figure 4: CDX011-04_ADEFI.sas;
CDX011-04_ADTTE.sas

Table 1: CDX011-04_ADSL.sas;
CDX011-04_ADMH.sas

Table 2: CDX011-04_ADEF.sas;
CDX011-04_ADEFI.sas; CDX011-04_ADTTE.sas

Table 3: CDX011-04_RawPK.xls

Table 4: CDX011-04_ADAE.sas

Supplemental
Table 1: CDX011-04_ADCM.sas

Supplemental
Table 2: CDX011-04_ADEF.sas; CDX011-04_ADEFI.sas; CDX011-04_ADTTE.sas

For
all data requests please contact Celldex at: [e-mail]

Name of Institutional
Review Board or ethics committee that approved the study

The study was conducted
at 120 sites in the United States, Canada, Australia, United Kingdom, France,
Spain, Belgium, Germany, and Italy. The study was conducted at each of the
participating institutions according to the Declaration of Helsinki and Good
Clinical Practice Guidelines, after approval by local institutional/ethics review
boards.

Clinical trial registry URL

https://www.clinicaltrials.gov/ct2/show/NCT01997333?term=NCT#01997333&draw=2&rank=1