A Biological Sample Collection Protocol of Women With and Without Breast Cancer: Hoosier Oncology Group Study BRE06-120 for the Analytical Proteomics Team

Inclusion Criteria:

FOR WOMEN WITH BREAST CANCER

- Histologically or cytologically confirmed invasive malignancy or ductal carcinoma in
situ of the breast.

- Preparing to begin a new regimen for breast cancer (adjuvant, locally recurrent, any
line metastatic).

- Female.

- Age > 18 years at the time of consent.

- Written informed consent and HIPAA authorization for release of personal health
information.

FOR HEALTHY VOLUNTEERS

- No known history of invasive malignancy or ductal carcinoma in situ. Volunteers must
not have prior history of malignancy in the past 5 years with the exception of basal
cell and squamous cell carcinoma of the skin. Other cancers with low potential for
metastasis, such as in situ cancers (e.g., Grade 1, TA TCC (low grade superficial
bladder cancer), colonic polyp with focus of adenocarcinoma) can also be enrolled as
healthy volunteers.

- Female

- Age > 18 years at the time of consent.

- Written informed consent and HIPAA authorization for release of personal health
information.

Exclusion Criteria:

- Females must not be pregnant.