Study of Tumor and Blood Samples From Women With Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: 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
Study Type
Observational
Study Phase
N/A
Study Design
N/A
Intervention
Name: laboratory biomarker analysis
Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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
Location
Institut Curie Hopital
Paris, France
Status: Recruiting
Contact: Paul-Henri Cottu - 33-3-8393-5005
Start Date
February 2008
Sponsors
Institut Curie
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page