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

Breast Neoplasms Clinical Trial

— GMPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256801
• Other study ID #: GMPE
• Status: Completed
• Phase: Phase 3
• First received: December 1, 2010
• Last updated: July 27, 2015
• Start date: November 2010
• Est. completion date: December 2013

Study information

• Verified date: July 2015
• Source: Beijing Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms
• Gene Expression Profiling
• Immunotherapy
• Neoplasm Metastasis
• Neoplasms
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Biological:
• cytokine
interleukin 2 2 million unit every week

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	immunotherapy response	Response of malignant pleural effusion to immunotherapy is evaluated with WHO guidelines	1 month	Yes
Secondary	immunological status	compare the immunological status of pleural effusion before and after the therapy	1 month	Yes