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

Inclusion Criteria:

• Women or men at least 18 years of age

• Pathologically documented diagnosis of measurable or evaluable metastatic breastcancer with known ER, PR, and HER2 status determined by the local laboratory on theprimary tumor.

• Enrolled before or during first line of treatment for metastatic breast cancer. Nomore than 1 prior line of therapy in the metastatic setting.

• Accessible medical records for all treatment and response data in the metastaticsetting.

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

• Receiving treatment for metastatic breast cancer.

• Treating physician considers patient well enough for standard of care therapyincluding chemotherapy.

• Willing to give blood for research purposes upon study enrollment and at firstdisease progression.

• Available archival primary tumor suitable for molecular analysis. If the primary isnot available, willingness to obtain extra samples for research during plannedstandard of care biopsy, or willingness to undergo biopsy for repeat clinicalreceptors and molecular analyses.

• Archival metastatic sample available and suitable for molecular analysis. If notavailable, willingness to undergo biopsy for repeat clinical receptors and molecularanalyses. If no archival metastatic sample is available and the metastasis is notamenable to biopsy per treating physician the patient may still be enrolled.

• Be willing and capable of providing informed consent, recognize the experimentalnature of the trial, and sign the IRB-approved written informed consentdocumentations

Exclusion Criteria:

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

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