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Study of Tumor and Blood Samples From Women With Breast Cancer

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ClinicalTrials.gov Identifier: NCT00897728
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : May 12, 2009
Last Update Posted : December 1, 2010
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease Intervention/treatment
Breast Cancer Other: laboratory biomarker analysis

Detailed Description:

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.


Study Design
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Study Type : Observational
Estimated Enrollment : 180 participants
Official Title: Colon and Breast Cancer Diagnostics. Clinical Protocol Associated With Cancer of the Breast.
Study Start Date : February 2008
Estimated Primary Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Local or remote relapse as assessed by biomarkers in tissue and blood samples collected during the first 2 years after diagnosis

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT00897728


Locations
France
Institut Curie Hopital Recruiting
Paris, France, 75248
Contact: Paul-Henri Cottu    33-3-8393-5005      
Sponsors and Collaborators
Institut Curie
Investigators
Study Chair: Paul-Henri Cottu Institut Curie
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00897728     History of Changes
Other Study ID Numbers: CDR0000599189
CLCC-IC-COBRED-SEIN
CLCC-IC-2007-11
CLCC-RECF0632
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: December 1, 2010
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
 stage IIIC breast cancer
HER2-positive breast cancer
triple-negative breast cancer
estrogen receptor-negative breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases