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


Phase 3
18 Years
75 Years
Open (Enrolling)
Female
Breast Neoplasms, Neoplasm Metastasis, Gene Expression Profiling, Immunotherapy

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

immunotherapy response

Outcome Description:

Response of malignant pleural effusion to immunotherapy is evaluated with WHO guidelines

Outcome Time Frame:

1 month

Safety Issue:

Yes

Principal Investigator

JUN REN, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beijing Cancer Hospital

Authority:

China: Ministry of Health

Study ID:

GMPE

NCT ID:

NCT01256801

Start Date:

November 2010

Completion Date:

December 2014

Related Keywords:

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

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