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Study of Tumor and Blood Samples From Women With Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Locations
France
Study Type
Observational
Intervention
laboratory biomarker analysis
Sponsored by
Institut Curie
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Curie HopitalRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 9, 2009
Last Updated
November 30, 2010
Sponsor
Institut Curie
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1. Study Identification

Unique Protocol Identification Number
NCT00897728
Brief Title
Study of Tumor and Blood Samples From Women With Breast Cancer
Official Title
Colon and Breast Cancer Diagnostics. Clinical Protocol Associated With Cancer of the Breast.
Study Type
Observational

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Institut Curie

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
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

7. Study Design

Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Primary Outcome Measure Information:
Title
Local or remote relapse as assessed by biomarkers in tissue and blood samples collected during the first 2 years after diagnosis

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul-Henri Cottu
Organizational Affiliation
Institut Curie
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Curie Hopital
City
Paris
ZIP/Postal Code
75248
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul-Henri Cottu
Phone
33-3-8393-5005

12. IPD Sharing Statement

Learn more about this trial

Study of Tumor and Blood Samples From Women With Breast Cancer

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