Triple Negative Breast Cancer Biomarker Study

Patients with metastatic or locally recurrent triple negative breast cancer (TNBC) who are
scheduled for medically indicated surgical biopsy or resection of disease will be
identified. Fresh/frozen tissue will be collected and will undergo comprehensive molecular
evaluation with NextGen sequencing. TGEN's clonal genomics analyses will be applied in the
analysis to identify and prioritize the mutated targets. Therapeutic options, based on the
genetic profile of each patient's tumor, will be discussed and an appropriate
molecularly-selected agent will be recommended by the Study Investigator(s) (SI) and
treating oncologist as treatment for the patient.

This is an open-label, pilot trial. Patients with metastatic or locally recurrent TNBC who
are scheduled for medically indicated surgical biopsy or resection will be enrolled and
therapeutic options, based on the genetic profile of each patient's tumor, will be discussed
with the patient.

Time-to-progression (TTP) for these patients following the selected therapy is the primary
objective and will be compared to the TTP(s) for their most recent prior therapy. A 30%
increase in TTP with the molecularly-targeted agent compared with the TTP on the immediate
prior therapy will be considered as evidence of clinical benefit from the selected therapy.
The secondary endpoints are best response to the molecularly-selected therapy, overall
survival (OS) and genetic mutation evaluation in metastatic (or locally recurrent) TNBC.

The study is designed to demonstrate that the collection and analysis of these tumor samples
is feasible.