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Study of Tumor and Blood Samples From Women With Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00897728
First received: May 9, 2009
Last updated: November 30, 2010
Last verified: July 2009
History of Changes

May 9, 2009
November 30, 2010
February 2008
February 2010   (final data collection date for primary outcome measure)
Local or remote relapse as assessed by biomarkers in tissue and blood samples collected during the first 2 years after diagnosis [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00897728 on ClinicalTrials.gov Archive Site
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Study of Tumor and Blood Samples From Women With Breast Cancer
Colon and Breast Cancer Diagnostics. Clinical Protocol Associated With Cancer of the Breast.

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at tumor and blood samples from women with breast cancer.

OBJECTIVES:

Primary

  • Assess relapse locally or remotely using biomarkers collected from primary tumor and blood samples from women with breast cancer during the first 2 years after diagnosis.

Secondary

  • Evaluate all relapses.
  • Assess survival without relapse.
  • Determine correlation between biomarkers and relapse.

OUTLINE: Primary tumor and blood samples collected during usual care of patients during the first 2 years after diagnosis are analyzed for biomarkers useful in monitoring and diagnosing breast cancer.
Observational
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Breast Cancer
Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
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February 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
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France
 
NCT00897728
CDR0000599189, CLCC-IC-COBRED-SEIN, CLCC-IC-2007-11, CLCC-RECF0632
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Institut Curie
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Study Chair: Paul-Henri Cottu Institut Curie
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP