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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT00897728 |
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Date of registration:
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09/05/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Tumor and Blood Samples From Women With Breast Cancer
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Scientific title:
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Colon and Breast Cancer Diagnostics. Clinical Protocol Associated With Cancer of the Breast. |
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Date of first enrolment:
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February 2008 |
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Target sample size:
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180 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00897728 |
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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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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Paul-Henri Cottu |
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Address:
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Telephone:
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33-3-8393-5005 |
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Email:
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Affiliation:
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Name:
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Paul-Henri Cottu |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut Curie |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Diagnosis of infiltrating unilateral breast cancer
- No in situ disease (ductal or lobular)
- No invasive bilateral synchronous disease
- Breast cancer at high risk, defined by at least 2 of the following factors:
- Hormone receptor negative (HR-)
- Axillary node positive
- Histopathologic grade III
- High mitotic index (as defined by the Curie Institute as > 20 mitoses per 10
high-power fields [HPF])
- Tumor size = 2 cm
- HER2-positive (3 + IHC or FISH/ICHS positive)
- Triple-negative tumors (HR- and HER2-negative)
- Initial thoracic-abdomino-pelvic and bone scans must be negative
- Underwent initial surgery
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Serum calcium normal (15.3 mg/dL) or normalized within 8 weeks after surgery
- No other invasive cancer within the past 5 years
- Not pregnant or nursing
- No psychological, familial, social, or geographical reasons that make monitoring
impossible
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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Intervention(s)
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Other: laboratory biomarker analysis
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Primary Outcome(s)
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Local or remote relapse as assessed by biomarkers in tissue and blood samples collected during the first 2 years after diagnosis
[Time Frame: No]
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Secondary ID(s)
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CLCC-IC-2007-11
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CLCC-RECF0632
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CDR0000599189
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CLCC-IC-COBRED-SEIN
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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