Breast Cancer
Conditions
Keywords
stage IV breast cancer
Brief summary
RATIONALE: Measuring blood levels of tumor cells in patients with breast cancer may help doctors predict how patients will respond to treatment. PURPOSE: This laboratory study is looking at blood levels of tumor cells in predicting response in patients receiving first-line chemotherapy for stage IV breast cancer.
Detailed description
OBJECTIVES: Primary * Predict the overall and progression-free survival of patients with stage IV breast cancer by measuring the rate of circulating tumor cells (CTC) before the second course of chemotherapy. Secondary * Predict overall and progression-free survival of these patients by measuring the rate of CTC before the start of chemotherapy, at the first tumor evaluation, and after 2-3 courses of chemotherapy. * Correlate the detection of CTC with tumor markers, clinical response, and radiological response. * Study the changing status of HER-2 in CTC in patients receiving trastuzmab (Herceptin®). OUTLINE: This is a multicenter study. Blood samples are collected at baseline, before the second course of chemotherapy, before the third or fourth course of chemotherapy, and when progressive disease is diagnosed (before second-line treatment is initiated). Circulating tumor cells from the blood samples are examined by immunofluorescence. Patients are followed periodically for up to 3 months.
Interventions
GENETICfluorescence in situ hybridization
OTHERimmunologic technique
OTHERlaboratory biomarker analysis
Sponsors
Institut Curie
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of stage IV breast cancer * Measurable or evaluable disease * Scheduled to receive first-line chemotherapy with or without trastuzumab (Herceptin®), depending on HER-2 status * Histologic block available for confirming pathologic diagnosis and measuring HER-2 status via FISH PATIENT CHARACTERISTICS: * Life expectancy \> 3 months * No other cancer in the past 5 years except for basal cell skin cancer or epithelial in situ cancer of the cervix * No geographic, social, or psychiatric reasons that would make treatment impossible PRIOR CONCURRENT THERAPY: * No prior chemotherapy for metastatic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation of circulating tumor cells (CTC) with overall survival | — |
| Correlation of CTC with progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of circulating tumor cells with tumor markers, clinical response, and radiological response | — |
| Change in HER-2 status in patients receiving trastuzumab (Herceptin®) | — |
Countries
France
Outcome results
None listed