Harnessing Analysis RNA Expression and Molecular Subtype to Optimize Novel TherapY MBCA

Primary Objectives:

1. To determine if clinical:molecular subtypes differ from expected results 15% of time

2. To determine if molecular information alters treatment plans, as perceived by treating
physican through survey

Subjects will be consented to the trial and archival tissue from primary tumor will be
obtained. Stored tissue from metastatic sites will also be obtained. The physician will be
asked what the preferred medications for next two lines of treatment. PAM50 testing to
determine molecular subtype will be determined on primary and metastatic tissue. The
molecular subtype results of the primary tissue will be returned to the physician, and the
physician will again be asked the preferred medications for the next two lines of treatment.
The number of times these medications change between the first and second surveys will be
determined.

Subjects active participation will only last as long as the consent process.

Inclusion Criteria:

- Women or men at least 18 years of age

- Pathologically documented diagnosis of measurable or evaluable metastatic breast
cancer with known ER, PR, and HER2 status determined by the local laboratory on the
primary tumor.

- Enrolled before or during first line of treatment for metastatic breast cancer. No
more than 1 prior line of therapy in the metastatic setting.

- Accessible medical records for all treatment and response data in the metastatic
setting.

- Willing and able to receive medical treatment or follow up by investigators at
UNC-Chapel Hill.

- ECOG Performance status 0-1. Participants must have estimated life expectancy > 12
weeks and be well enough according to their treating physician that they will receive
at least 2 additional lines of anticancer therapy.

- Receiving treatment for metastatic breast cancer.

- Treating physician considers patient well enough for standard of care therapy
including chemotherapy.

- Willing to give blood for research purposes upon study enrollment and at first disease
progression.

- Available archival primary tumor suitable for molecular analysis. If the primary is
not available, willingness to obtain extra samples for research during planned
standard of care biopsy, or willingness to undergo biopsy for repeat clinical
receptors and molecular analyses.

- Archival metastatic sample available and suitable for molecular analysis. If not
available, willingness to undergo biopsy for repeat clinical receptors and molecular
analyses. If no archival metastatic sample is available and the metastasis is not
amenable to biopsy per treating physician the patient may still be enrolled.

- Be willing and capable of providing informed consent, recognize the experimental
nature of the trial, and sign the IRB-approved written informed consent documentations

Exclusion Criteria:

- Does not have tissue available or suitable for molecular analysis, or is unwilling to
provide tissue for research at the time of a clinically indicated procedure.

- Has dementia, altered mental status, or any psychiatric or co-morbid condition
prohibiting the understanding or rending of informed consent.