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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00897299 |
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Date of registration:
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09/05/2009 |
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Primary sponsor: |
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Public title:
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Identifying Genes That Predict Recurrence in Women With Breast Cancer Treated With Chemotherapy
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Scientific title:
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Identifying Genomic Predictors of Recurrence After Adjuvant Chemotherapy |
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Date of first enrolment:
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November 2004 |
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Target sample size:
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900 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00897299 |
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Study type:
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Observational |
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Study design:
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N/A
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Contacts
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Name:
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Joseph A. Sparano, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Albert Einstein College of Medicine of Yeshiva University |
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Name:
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Lori J. Goldstein, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fox Chase Cancer Center |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer
- Node positive OR high-risk node negative disease
- Tumor > 1.0 cm in diameter
- No locally advanced, inflammatory, or metastatic breast cancer
- Previously treated with 4 courses of anthracycline-containing chemotherapy (i.e.,
doxorubicin and docetaxel OR doxorubicin and cyclophosphamide)
- Enrolled on clinical trial ECOG-E2197
- Adequate tumor material available in ECOG Pathology Coordination Center
- Previously consented to future cancer-related research
- Hormone receptor status known
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Estrogen Receptor
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Her-2
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Pgr
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Intervention(s)
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Genetic: microarray analysis
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Genetic: protein expression analysis
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Other: immunohistochemistry staining method
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Other: laboratory biomarker analysis
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Primary Outcome(s)
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Distant, local/regional, and ipsilateral breast relapse
[Time Frame: No]
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First breast cancer recurrence
[Time Frame: No]
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Relapse-free interval
[Time Frame: No]
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Secondary Outcome(s)
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Disease-free survival
[Time Frame: No]
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Distant involvement at time of first recurrence
[Time Frame: No]
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Overall survival
[Time Frame: No]
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Secondary ID(s)
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CDR0000456426
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ECOG-E21971CSC
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GENOMIC-ECOG-E21971CSC
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NCI-7613
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SANOFI-AVENTIS-ECOG-E21971CSC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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