Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study: Hoosier Oncology Group COE-01

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the breast with locally
advanced or metastatic disease.

- Disease amenable to pre-treatment core or incisional biopsy with adequate tissue for
histology and genomic/proteomic analysis.

- Measurable disease as assessed within 21 days prior to being registered for protocol
therapy by RECIST.

- Planned chemotherapy with one of the following regimens:

1. Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle

2. Capecitabine 1000 mg/m2 BID days 1-14 of every 21-day cycle

3. Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle

4. Gemcitabine 1000 mg/m2 days 1, 8, 15 of every 28-day cycle

Exclusion Criteria:

- No serious uncontrolled medical or surgical condition that the investigator feels
might compromise study participation.

- Negative pregnancy test obtained within 7 days prior to being registered for protocol
therapy for women of child bearing potential.

- Unwillingness to use adequate contraception (or practicing complete abstinence).
Subjects should be advised that adequate contraception (or complete abstinence) must
be continued while on treatment and for a period of 3 months after the final dose of
chemotherapy.

- No breast-feeding.