Breast Cancer Clinical Trial
Official title:
Identifying Genomic Predictors of Recurrence After Adjuvant Chemotherapy
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may
help doctors learn more about changes that occur in DNA and identify biomarkers related to
cancer. It may also help doctors predict whether cancer will come back after treatment.
PURPOSE: This laboratory study is identifying genes that may help predict recurrence in
women with breast cancer treated with 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.
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