Study of Tumor and Blood Samples From Women With Breast Cancer

November 30, 2010 updated by: Institut Curie

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75248
        • Recruiting
        • Institut Curie Hopital
        • Contact:
          • Paul-Henri Cottu
          • Phone Number: 33-3-8393-5005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Local or remote relapse as assessed by biomarkers in tissue and blood samples collected during the first 2 years after diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Curie

Investigators

  • Study Chair: Paul-Henri Cottu, Institut Curie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Anticipated)

February 1, 2010

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

December 1, 2010

Last Update Submitted That Met QC Criteria

November 30, 2010

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000599189
  • CLCC-IC-COBRED-SEIN
  • CLCC-IC-2007-11
  • CLCC-RECF0632

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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