Status:
UNKNOWN
Study of Tumor and Blood Samples From Women With Breast Cancer
Lead Sponsor:
Institut Curie
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
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....
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. Seco...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00897728
Start Date
February 1 2008
Last Update
December 1 2010
Active Locations (1)
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1
Institut Curie Hopital
Paris, France, 75248