Trial Information

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.

OUTLINE: This is a multicenter study.

Fixed paraffin-embedded breast tumor tissue samples (obtained from the SWOG Central Tumor
Repository at the University of Colorado) are analyzed by the Oncotype DX panel containing
the following 21 genes: BAG1, Bc12, CCNB1, CD68, SCUBE2, CTSL2, Esrt1, GRB7, GSTM1, HER2,
Ki-67, MYBL2, PR, STK15, STMY3, SURV, B-actin, GAPDH, GUS, RPLPO, and TFRC. The Oncotype DX
Recurrence Score is calculated for each patient. Analyses are performed to determine the
relationship between the Recurrence Score and gene expression and prognosis/prediction of
therapy (tamoxifen citrate alone or cyclophosphamide, doxorubicin hydrochloride, and
fluorouracil with concurrent or sequential tamoxifen citrate) benefit as well as to
determine the relationship between clinical and demographic covariates and disease-free and
overall survival.

Samples are also analyzed by reverse-transcriptase-polymerase chain reaction for exploratory
analysis of up to 800 additional genes that may be prognostic and/or predict the likelihood
of therapy benefit.