Study of High-dose Chemotherapy (HDC) Combined With Adoptive Cellular Therapy With DC-CIK Cells in Triple Negative Breast Cancer Patients (DC-CIK)
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|ClinicalTrials.gov Identifier: NCT01232062|
Recruitment Status : Completed
First Posted : November 2, 2010
Last Update Posted : July 23, 2015
|Condition or disease|
|Breast Neoplasms Neoplasm Metastasis|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||46 participants|
|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|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||October 2013|
- response to chemotherapy [ Time Frame: 4months ]Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST).
- Time to disease progression [ Time Frame: six months to one year ]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 ]
- clinical benefit response [ Time Frame: six months to one year ]clinical benefit response include CR,PR,SD
Biospecimen Retention: None Retained
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01232062
|Beijing Cancer Hospital|
|Beijing, China, 100142|
|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|