A Correlative Study for Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer

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:

Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
Capecitabine 1000 mg/m2 BID days 1-14 of every 21-day cycle
Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle
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.