Identifying Genes That Predict Recurrence in Women With Breast Cancer Treated With 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.
|Breast Cancer Estrogen Receptor Her-2 Pgr||Genetic: microarray analysis Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis|
|Official Title:||Identifying Genomic Predictors of Recurrence After Adjuvant Chemotherapy|
- Distant, local/regional, and ipsilateral breast relapse
- First breast cancer recurrence
- Relapse-free interval
- Distant involvement at time of first recurrence
- Disease-free survival
- Overall survival
|Actual Study Start Date:||October 7, 2005|
|Study Completion Date:||October 8, 2005|
|Primary Completion Date:||October 8, 2005 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897299
|Study Chair:||Joseph A. Sparano, MD||Albert Einstein College of Medicine, Inc.|
|OverallOfficial:||Lori J. Goldstein, MD||Fox Chase Cancer Center|