Clinical trial · Observational
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
NCT01256801CI-TRIAL-00018705GMPEcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Gene Expression Profiling | — | UNRESOLVED | — |
| Immunotherapy | — | UNRESOLVED | — |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytokine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- cytokine
- description
- The patients are randomized to receive the cytokine infusion in the pleural cavity
- interventionNames
- Biological: cytokine
Primary outcomes (1)
- measure
- immunotherapy response
- timeFrame
- 1 month
- description
- Response of malignant pleural effusion to immunotherapy is evaluated with WHO guidelines
Secondary outcomes (1)
- measure
- immunological status
- timeFrame
- 1 month
- description
- compare the immunological status of pleural effusion before and after the therapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.