This is a study to evaluate the performance of neoadjuvant treatment using genomic guided assignment to chemotherapy in early-stage breast cancer.

Subjects will receive doxorubicin/cyclophosphamide (AC) or docetaxel/cyclophosphamide (TC) and will be randomized to genomic guided or non-genomic guided treatment.

For those randomized to the genomic guided arm (group 1), subjects will receive the chemotherapy regimen (AC or TC) to which they show a greater than or equal to 60 percent likelihood of sensitivity. Subjects with less than 60 percent sensitivity or on the non-genomic guided treatment arm (group 2), will be randomized to AC or TC.

Eligibility

Subjects must have stage T1c to T3 HER2 negative invasive breast cancer, amenable to surgical resection. Subjects with HER2 positive breast cancer are excluded because the standard of care for these subjects includes trastuzumab and the regimens being studied would not be acceptable.

This study will be open to male and female patients (18 years of age or older) of all demographic groups who meet the eligibility criteria. Fresh frozen tumor must be available for genomics analysis prior to randomization. If fresh frozen tissue is not available, subjects must undergo a biopsy to participate in the study.

Requirements

After genomic analysis is completed (seven to 10 business days), subjects will be randomized and start the assigned chemotherapy every three weeks for four cycles as neoadjuvant therapy. Imaging studies will be done after the four cycles and prior to surgery to assess radiologic response to therapy.

If the subject’s cancer has not responded or minimally responded to chemotherapy, the physician may offer additional medical therapy. Before receiving additional medical therapy, subjects will be asked to undergo an additional biopsy for research purposes.

If the subject’s cancer has responded, then the subject will undergo surgical resection approximately four to five weeks after the last chemotherapy. The surgical specimen will be evaluated for pathologic response and changes in the genomic expression profile.

Subjects will be seen one to two weeks after surgery and then followed for 10 years per standard clinical practice.

A simple questionnaire assessing knowledge of genomics will be obtained at baseline and at completion of chemotherapy or progression of disease during chemotherapy, and following surgery.

Compensation

Subjects will not receive compensation for participation in this study.