Trial Information

Identifying Genomic Predictors of Recurrence After Adjuvant Chemotherapy

OBJECTIVES:

- Assess the prognostic utility of the Oncotype DX™ 21 gene profile for risk of relapse
in women with node positive or high-risk node negative breast cancer.

- Identify individual genes whose RNA expression is associated with an increased risk of
relapse in these patients.

- Perform an exploratory analysis of individual genes whose RNA expression is associated
with an increased risk of relapse differentially in patients previously treated with
docetaxel.

OUTLINE: This is a multicenter study.

Tissue samples are examined for association of RNA expression and clinical factors (e.g.,
tumor size, nodal status, hormone receptor status, age, menopause status), as well as
estrogen receptor, progesterone receptor, and HER-2/neu expression by immunohistochemistry
and other studies.

PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study.