Genomic Signatures to Predict Treatment Response
Genomic Signatures to Predict Treatment Response
A genomic test was developed to predict chemo-sensitivity to taxane-anthracycline-based
 chemotherapy as neoadjuvant treatment. The primary aim of this study is to prospectively
 evaluate the microarray-based, genomic test as a predictor of axillary lymph node response.
 Also, to determine whether the probability of achieving negative axillary nodes, is
 sufficiently high for patients whose breast cancer is predicted to be chemo-sensitive to
 support omitting axillary dissection.
Inclusion Criteria:

 -  Clinical status of lymph nodes must be available

 -  Sonographical status of lymph nodes must be available

 -  Patients must consent to documentation of cancer treatment

 -  Histologic diagnosis of invasive breast cancer, clinical stage T1-4, M0
 (non-inflammatory T4c)

 -  Patients scheduled for neoadjuvant chemotherapy

 -  Treatment with a 3-weekly FEC or AC regimen (3-4 cycles) followed by 3-4 cycles of q3
 weekly docetaxel or paclitaxel.

 -  Local HER2 status of tumor biopsy must be negative.

 Exclusion Criteria:

 -  The patient has a prior history of invasive or metastatic breast cancer.

 -  The patient had prior excisional biopsy of the primary invasive breast cancer.

 -  The patient had prior ipsilateral sentinel axillary lymph node biopsy for breast
 cancer.

 -  The patient cannot safely or feasibly undergo biopsy of the primary tumor.

 -  The patient has a diagnosis of Stage IV (distant metastatic) breast cancer.

 -  The patient has proven HER2-positive breast cancer, defined as a pathology report of
 amplification of the gene or 3+ score for immunohistochemical staining.