Study of Tumor and Blood Samples From Women With Breast Cancer

Institut Curie

Status: Unknown

Conditions: Breast Cancer

Treatments: Other: laboratory biomarker analysis

Study type: Observational

Funder types: Other

Identifiers

NCT00897728

CLCC-IC-COBRED-SEIN

CLCC-IC-2007-11

CLCC-RECF0632

CDR0000599189

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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