Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Institut Curie
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
