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

NCT01256801 | Completed DMC

• 1 other identifier: GMPE
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Neoplasm Metastasis; Gene Expression Profiling; Immunotherapy

Keywords

Metastatic Breast Neoplasms; Gene Expression Profiling; immunotherapy

Outcome Measures

Primary Outcomes (1)

• immunotherapy response

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

  1 month

Secondary Outcomes (1)

• immunological status

  1 month

Study Arms (1)

cytokine

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

Biological: cytokine

Interventions

cytokine BIOLOGICAL

interleukin 2 2 million unit every week

Also known as: interleukin 2 2 million unit every week

cytokine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The breast cancer patiets present with pleural effusion and can receive chemotherapy.

You may qualify if:

• 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

You may not qualify if:

• previous history of other malignancies;
• previous surgery history on the needle biopsy organ;
• Serious or uncontrolled concurrent medical illness.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, 100142, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The cancer cells are taken from the malignant pleural effusion of breast cancer patiets.

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Cytokines

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• JUN REN, MD

  Peking University Cancer Hospital & Institute

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 9, 2010
• Study Start: November 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 29, 2015

Record last verified: 2015-07

Locations

CN (1)