Breast Neoplasms Clinical Trial
— GMPEOfficial title:
Gene Expression Profiling of Breast Cancer Cells in Pleural Effusion Prodict the Response of Malignant Pleural Effusion to Immunotherapy
Verified date | July 2015 |
Source | Beijing Cancer Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ministry of Health |
Study type | Observational |
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.
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
China | Beijing Cancer Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Cancer Hospital |
China,
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 |
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