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
  Purpose

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 Intervention
Breast Cancer
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Colon and Breast Cancer Diagnostics. Clinical Protocol Associated With Cancer of the Breast.

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 180
Study Start Date: February 2008
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00897728     History of Changes
Other Study ID Numbers: CDR0000599189, CLCC-IC-COBRED-SEIN, CLCC-IC-2007-11, CLCC-RECF0632
Study First Received: May 9, 2009
Last Updated: November 30, 2010
Health Authority: Unspecified

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

ClinicalTrials.gov processed this record on August 21, 2014