Phase II Trial for Large ER-Negative Breast Cancers
Status:
Completed
Trial end date:
2010-08-21
Target enrollment:
Participant gender:
Summary
A primary objective of this study is to evaluate the in vivo response of tumor to
chemotherapy through gene microarray analysis. Neoadjuvant treatment allows the unique
opportunity to observe the in vivo effects of cytotoxic therapy on gene expression in tumor
tissue. The investigators plan to evaluate several different questions by comparing gene
profiles in different phases of treatment in this study. These are outlined below.
Hypotheses
1. Chemotherapy enriches for tumor cell populations that have enhanced resistance and
survival mechanisms. These mechanisms will in part be identifiable through changes in
gene expression profiles pre vs. post treatment.
2. Use of two distinct chemotherapy selection pressures, for example a DNA-damaging regimen
(epirubicin and cyclophosphamide) or a mitotic spindle/metabolic targeted regimen
(docetaxel and capecitabine), will allow for the identification of a smaller set of
genes associated to resistance and survival mechanisms of broad importance.
3. Genes associated with enrichment for resistance and survival mechanisms will not be
present in large amounts pretreatment in tumors destined for complete pathologic
response.