Gene Expression Profiling of Breast Cancer Cells Predict the Response of Malignant Pleural Effusion

Study Overview
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Brief Summary
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The investigators want to develop a gene expression profile for the prediction of immunotherapy response of patients with metastatic breast cancer presenting malignant pleural effusion.

Detailed Description
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The patiets with malignant pleural effusion are randomizned to be treated with cytokins(inteleukin 2) or dendritic cells(DC) plus cytokine induced killer cells(CIK) locally. Malignant pleural effusion from metastatic breast cancer patient is obtained through thoracentesis and is centrifugalized to enrich cancer cells before the therapy. The enriched cancer cells are flash frozen and stored at -80℃ until processing. The gene expression in pleural effusion is detected by microarray to screen gene markers that are differently expressed between groups . Statistical analysis is performed using unsupervised hierarchical cluster.

Official Title
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Gene Expression Profiling of Breast Cancer Cells in Pleural Effusion Prodict the Response of Malignant Pleural Effusion to Immunotherapy

Conditions
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Breast Neoplasms, Neoplasm Metastasis, Gene Expression Profiling, Immunotherapy

Intervention / Treatment
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* Biological: cytokine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients should be histologically confirmed with metastatic breast cancer and malignant pleural effusion an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; At least one measurable lesion; Normal cardiac, hepatic, renal and bone marrow functions; Life expectancy ≥3 months; Discontinuity of previous chemotherapy for a minimum of 4 weeks. Not receive chemotherapy in pleural cavity Exclusion Criteria: previous history of other malignancies; previous surgery history on the needle biopsy organ; Serious or uncontrolled concurrent medical illness.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cytokine<br>The patients are randomized to receive the cytokine infusion in the pleural cavity | Biological: cytokine<br>* interleukin 2 2 million unit every week<br>* Other names: interleukin 2 2 million unit every week;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunotherapy response | Response of malignant pleural effusion to immunotherapy is evaluated with WHO guidelines | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunological status | compare the immunological status of pleural effusion before and after the therapy | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic Breast Neoplasms, Gene Expression Profiling, immunotherapy