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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01256801

Acronym

GMPE

Enrollment

Registered

2010-12-09

Start date

2010-11-30

Completion date

2013-12-31

Last updated

2015-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms, Neoplasm Metastasis, Gene Expression Profiling, Immunotherapy

Keywords

Metastatic Breast Neoplasms, Gene Expression Profiling, immunotherapy

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.

Interventions

BIOLOGICALcytokine

interleukin 2 2 million unit every week

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
immunotherapy response	1 month	Response of malignant pleural effusion to immunotherapy is evaluated with WHO guidelines

Secondary

Measure	Time frame	Description
immunological status	1 month	compare the immunological status of pleural effusion before and after the therapy

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026