Relationship of pAKT to Survival in Patients With Node-Positive Breast Cancer



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:January 2004
End Date:December 2010

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Levels of Phosphorylated AKT in Patients With Node-Positive Breast Cancer: Correlation With Disease-Free and Overall Survival

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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
?
mi
from
Bethesda, MD
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