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

Completed

• Conditions: Neoplasm Metastasis; Breast Neoplasms; Gene Expression Profiling; Immunotherapy
• Interventions: Biological: cytokine

• Registration Number: NCT01256801
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief Summary

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

1. 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.

2. Malignant pleural effusion from metastatic breast cancer patient is obtained through thoracentesis and is centrifugalized to enrich cancer cells before the therapy.

3. The enriched cancer cells are flash frozen and stored at -80℃ until processing.

4. The gene expression in pleural effusion is detected by microarray to screen gene markers that are differently expressed between groups .

5. Statistical analysis is performed using unsupervised hierarchical cluster.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-12-01
• Study First Submitted QC: 2010-12-08
• Study First Posted: 2010-12-09
• Primary Completion: 2013-01
• Study Completion: 2013-12
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cytokine	cytokine	The patients are randomized to receive the cytokine infusion in the pleural cavity

Primary Outcome Measures

Name	Time	Method
immunotherapy response	1 month	Response of malignant pleural effusion to immunotherapy is evaluated with WHO guidelines

Secondary Outcome Measures

Name	Time	Method
immunological status	1 month	compare the immunological status of pleural effusion before and after the therapy

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, China