Study of Chemotherapy With Adoptive Cellular Therapy With DC-CIK Cells in Triple Negative Breast Cancer Patients (DCCIK)
To access the effectiveness of cyclophosphamide combined thiotepa and carboplatin chemotherapy combined with adoptive cellular therapy with dendritic and cytokine-induced killer cells in triple negative metastatic breast cancer patients
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Study of Chemotherapy Combined With Adoptive Cellular Therapy With Dendritic and Cytokine-induced Killer Cells in Triple Negative Breast Cancer Patients|
- progression-free survival [ Time Frame: six months to two year ] [ Designated as safety issue: Yes ]progression-free survivalis measured from the date therapy is initiated to the date of documented disease progression or death
- clinical benefit response and overall survival [ Time Frame: six months to two year ] [ Designated as safety issue: Yes ]clinical benefit response include complete release(CR), partial release (PR), stable disease (SD).
Biospecimen Retention: None Retained
about 4ml peripheral vein blood，paraffin section on metastatic tissue，
|Study Start Date:||July 2011|
|Study Completion Date:||June 2015|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
- Metastatic breast cancer patients should be definitively diagnosis based on histopathology, with ER-negative and PR-negative, FISH testing for her-2-negative
- All the patients enrolled will be given standard cyclophosphamide combined thiotepa and carboplatin chemotherapy and cellular therapy.Cellular therapy consisting of one cycle of chemotherapy followed by an apheresis and ex vivo cultures to generate DC and CIK, followed by low-dose Oral Cyclophosphamide .
- The response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines.
- Estimate time to progression, survival rates and clinical benefit response on patients.
- Find biomarkers associated with drug response.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395056
|Beijing Cancer Hospital|
|Beijing, China, 100142|
|Principal Investigator:||Jing Yu, MD, PhD||Beijing Cancer Hospital|