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Results

Clinical Trials
We identified 224 trials actively recruiting MBC patients in the US from the NCI’s PDQ dataset:
169 testing targeted therapies, 35 testing chemotherapies, and 20 that were targeted to a
specific metastatic tumor at a new organ site (e.g., brain, bone, liver, lung) (see Table 2). On
August 1, 2014, we reviewed the status of each of the 224 trials on Clinicaltrials.gov to see
whether they were still active and identified 2 trials that had completed enrollment and are
no longer recruiting, 2 that were terminated, and 8 that had a trial status updated to “unknown”.
We kept all 12 of these in the data analysis but noted recent trials in Appendix 1.

Trials of Targeted Therapies
We found that 162 of the 169 targeted therapy clinical trials could be assigned to the Hallmarks
of Cancer framework (see Figure 3). However, some molecular targets and some drugs may
have an effect on more than 1 hallmark pathway and thus could be assigned to more than 1
framework category. Table 2 summarizes the trials by hallmark category and phase (I, II, or III).
There are 95 trials of drugs that target 8 molecular pathways involved in sustaining proliferative
signaling, 27 trials testing drugs that target mechanisms of immune escape, 25 trials of drugs
that target 2 pathways related to genomic instability and mutation, 1 trial in the hallmark of
resisting cell death, 1 in the hallmark of activating invasion and metastasis, 4 trials assigned to
the hallmark of inducing angiogenesis, and 9 in the hallmark of evading growth suppressors.
The remaining 7 trials of the 169 total were categorized under “other”; 4 targeted heat-shock
proteins and 3 could not be assigned to a target. Altogether, the 169 trials for targeted therapies
included 74 phase I, 22 phase I/II, 54 phase II, and 17 phase III trials. Note that phase was not
listed for 2 targeted therapy clinical trials.

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