Study of Tumor and Blood Samples From Women With Breast Cancer

Study Overview
=================
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.

Official Title
-----------------
Colon and Breast Cancer Diagnostics. Clinical Protocol Associated With Cancer of the Breast.

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: laboratory biomarker analysis


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: laboratory biomarker analysis|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local or remote relapse as assessed by biomarkers in tissue and blood samples collected during the first 2 years after diagnosis |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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