Relationship of pAKT to Survival in Patients With Node-Positive Breast Cancer
Relationship of pAKT to Survival in Patients With Node-Positive Breast Cancer
This study will examine the relationship of a protein called pAKT to survival of breast
 cancer patients with one or more positive axillary lymph nodes. Akt plays a role in cell
 survival, tumor formation, and the development of drug resistance.

 The study will use tumor tissue obtained from 2,000 patients enrolled in a National Surgical
 Adjuvant Breast and Bowel Project study that is evaluating whether adding the drug paclitaxel
 (Taxol (Registered Trademark)) to a treatment regimen of doxorubicin (Adriamycin (Registered
 Trademark)) and cyclophosphamide (Cytoxan (Registered Trademark)) improves disease-free
 survival and overall survival in patients with node-positive breast cancer. The current study
 will measure levels of pAkt in the tissues and correlate the results with clinical outcome to
 see if pAkt levels are associated with improved patient survival.

 ...
Taxanes (paclitaxel and docetaxel) have emerged as the most powerful chemotherapeutics in
 breast cancer over the past decades. The B-28 clinical trial from the National Surgical
 Adjuvant Breast and Bowel Project (NSABP) assesses the efficacy of adding paclitaxel to the
 doxorubicin/cyclophosphamide regimen in the treatment of patients with axillary node positive
 breast cancer. The primary aim of B-28 is to determine whether four cycles of paclitaxel
 (Taxol (Registered Trademark)) (T) following four cycles of postoperative Doxorubicin
 (adriamycin (Registered Trademark) (A) and cyclophosphamide (C) will more effectively prolong
 disease-free survival (DFS) and survival (S) than four cycles of AC alone in patients with
 operable breast cancer who have one or more histologically positive axillary lymph nodes. The
 B-28 clinical trial tissue microarray consists of specimens from 2,000 cases enrolled. The
 tissue microarray set is an ideal platform for evaluating predictive markers of doxorubicin
 and/or paclitaxel response or resistance.

 Akt, a serine/threonine protein kinase regulated by the phosphatidylinositol 3-kinase (PI3K),
 is of importance in cell survival, tumorigenesis, and recently shown, chemoresistance. It
 confers survival advantage to cells by transducing signals from growth factor receptors that
 activate PI3K. The primary aim of this study is to evaluate whether the levels of
 phosphorylated AKT are associated with disease-free and overall survival in patients with
 node-positive breast cancer treated with AC and/or AC followed by paclitaxel.
-  INCLUSION CRITERIA

 The NSABP B-28 trial enrolled women from 1995 to 1998 with operable breast cancer with
 pathologically positive axillary lymph nodes.