Molecular Predictors of Outcome on CAF Plus Tamoxifen Versus Tamoxifen Alone in Postmenopausal Women With Node Positive, Receptor Positive Breast Cancer [NCI Correlative Science Reference No. # 8814A-ICSC]

OBJECTIVES:

Primary

• Determine the value of the Oncotype DX Recurrence Score for prediction of treatment benefit of cyclophosphamide, doxorubicin hydrochloride, and fluorouracil (CAF) chemotherapy, in terms of disease-free survival (DFS) and overall survival (OS), in postmenopausal patients with estrogen and/or progesterone receptor-positive, node-positive breast cancer treated on clinical trial SWOG-8814.
• Determine the overall prognostic value of the Oncotype DX Recurrence Score, in terms of DFS and OS, in patients treated with tamoxifen citrate alone or CAF with concurrent or sequential tamoxifen citrate.

Secondary

• Determine the optimal cut point (i.e., low, intermediate, and high recurrence risk) for the Recurrence Score in these patients.
• Determine the relationship between expression of any one of the 21 genes on the Oncotype DX gene panel with DFS and OS.
• Determine whether the expression of any of these genes are associated with CAF treatment benefit.
• Determine the relationship between the Oncotype DX Recurrence Score and DFS and OS in multivariate models, including number of positive nodes, tumor size, tumor grade, estrogen receptor, progesterone receptor, and HER2 and p53 status.
• Determine the relationship between quantitative reverse-transcriptase-polymerase chain reaction expression of up to 800 additional genes and prognosis and/or prediction of CAF benefit.