A Pilot Study Utilizing Proteomic and Genomic Profiling for Patients With Metastatic Breast Cancer

To examine the impact of targeted therapy for breast cancer based upon proteomic and genomic
profiling using RPMA, IHC analysis, RNA-Seq, and Exome sequencing on PFS and GMI.

Inclusion Criteria:

- Understand and provide written informed consent and HIPAA Authorization prior to
initiation of any study-specific procedures

- Have a life expectancy > 3 months

- Have a diagnosis of metastatic breast cancer with measurable disease (RECIST 1.1)

- Have progressed on ≥ 1 prior chemotherapeutic and/or hormonal regimen for advanced
disease.

- Have documentation of progression (by RECIST 1.1) on the treatment regimen
immediately prior to entering this study

- Be ≥ 18 years of age

- Have a ECOG score of 0-1

- Be a good medical candidate for and willing to undergo a biopsy or surgical
procedures to obtain tissue, which may or may not be part of the patient's routine
care for their malignancy. The requirements for the amount of tissue required for
analysis are detailed in Section 6.2.2.

- Have been off their prior regimen for ≥ 3 weeks or 5 x half-life of drug, whichever
is shorter and have recovered from the side effects (≤ grade 1) of that regimen

- Have adequate organ and bone marrow function

- Female patients of childbearing potential must have a negative pregnancy test and
agree to use at least one form of contraception during the study and for at least one
month after treatment discontinuation. For the purposes of this study, child-bearing
potential is defined as: all female patients that were not in post-menopause for at
least one year or are surgically sterile

- Male patients must use a form of barrier contraception approved by the investigator /
treating physician during the study and for at least one month after treatment
discontinuation.

Exclusion Criteria:

- Have a tumor biopsy intended for use in the current study that was performed more
than 2 months prior to analysis

- Have metastatic lesion that is not accessible to biopsy

- Had > 6 months treatment under the last line of therapy

- Have interventional cancer therapy conducted after the biopsy was collected prior to
analysis

- Have symptomatic CNS metastasis. Patients with a history of CNS metastases who have
been treated with whole brain irradiation must be stable without symptoms for 4 weeks
after completion of treatment, with image documentation required, and must be either
off steroids or on a stable dose of steroids for ≥ 2 weeks prior to enrollment

- Have any previous history of another malignancy (other than cured basal cell
carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of
study entry

- Have uncontrolled concurrent illness including, but not limited to, ongoing or active
serious infection, symptomatic congestive heart failure, unstable angina pectoris,
unstable cardiac arrhythmias, psychiatric illness, or situations that would limit
compliance with the study requirements or the ability to willingly give written
informed consent

- Have known HIV, HBV, HCV infection

- Are pregnant or breast-feeding patients or any patient with childbearing potential
not using adequate contraception.