Identifying Genes That Predict Recurrence in Women With Breast Cancer Treated With Chemotherapy
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|ClinicalTrials.gov Identifier: NCT00897299|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 17, 2017
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer Estrogen Receptor Her-2 Pgr||Genetic: microarray analysis Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||900 participants|
|Official Title:||Identifying Genomic Predictors of Recurrence After Adjuvant Chemotherapy|
|Actual Study Start Date :||October 7, 2005|
|Primary Completion Date :||October 8, 2005|
|Study Completion Date :||October 8, 2005|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897299
|Study Chair:||Joseph A. Sparano, MD||Albert Einstein College of Medicine, Inc.|
|OverallOfficial:||Lori J. Goldstein, MD||Fox Chase Cancer Center|