Study of Tumor and Blood Samples From Women With Breast Cancer

Institut Curie180 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

180

Conditions

Breast Cancer

Interventions

laboratory biomarker analysisOTHER

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Institut Curie Hopital

Paris, France

RECRUITING

Outcomes

Primary Outcomes

Local or remote relapse as assessed by biomarkers in tissue and blood samples collected during the first 2 years after diagnosis

Data from ClinicalTrials.gov

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