Study of High-dose Chemotherapy (HDC) Combined With Adoptive Cellular Therapy With DC-CIK Cells in Triple Negative Breast Cancer Patients
To access the effectiveness of High-dose Cyclophosphamide Combined Chemotherapy combined with adoptive cellular therapy with dentritic and cytokine-induced killer cells in triple negative metastatic breast cancer patients
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Study of High-dose Chemotherapy Combined With Adoptive Cellular Therapy With Dentritic and Cytokine-induced Killer Cells in Triple Negative Breast Cancer Patients|
- response to chemotherapy [ Time Frame: 4months ] [ Designated as safety issue: Yes ]Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST).
- Time to disease progression [ Time Frame: six months to one year ] [ Designated as safety issue: Yes ]Time to disease progression is measured from the date therapy is initiated to the date of documented disease progression.
- survival rates [ Time Frame: one-year ] [ Designated as safety issue: Yes ]
- clinical benefit response [ Time Frame: six months to one year ] [ Designated as safety issue: Yes ]clinical benefit response include CR,PR,SD
Biospecimen Retention: None Retained
about 4ml peripheral vein blood，paraffin section on metastatic tissue，
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2013 (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 HDC and cellular therapy.HDC and cellular therapy consisting of one cycle of HDC followed by an apheresis and ex vivo cultures to generate DC and CIK. DC-CIK infusions were given to each patient, followed by two cycles HDC, plus low-dose Oral Cyclophosphamide.
- PET-CT scans were done on each patients at baseline and after chemotherapy. 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: NCT01232062
|Contact: JUN REN, MD, PhDfirstname.lastname@example.org|
|Contact: JING YU, MD, PhDemail@example.com|
|Beijing Cancer Hospital||Recruiting|
|Beijing, China, 100142|
|Contact: JUN REN, MD and PhD +86-10-88196356 firstname.lastname@example.org|
|Principal Investigator:||JING YU, MD, PhD||Beijing Cancer Hospital|
|Principal Investigator:||CHAO YING WANG, MD, PhD||Beijing Cancer Hospital|
|Study Chair:||JUN REN, MD, PhD||Beijing Cancer Hospital|
|Principal Investigator:||YU LIN ZHU, MD, PhD||Bei jing Cancer Hospital|
|Principal Investigator:||Jie Zhang, MD.||Beijing Cancer Hospital|