Study of High-dose Chemotherapy Combined With Adoptive Cellular Therapy With Dentritic and Cytokine-induced Killer Cells in Triple Negative Breast Cancer Patients
1. Metastatic breast cancer patients should be definitively diagnosis based on
histopathology, with ER-negative and PR-negative, FISH testing for her-2-negative
2. 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.
3. 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.
4. Estimate time to progression, survival rates and clinical benefit response on patients.
5. Find biomarkers associated with drug response.
Observational
Observational Model: Cohort, Time Perspective: Retrospective
response to chemotherapy
Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST).
4months
Yes
JING YU, MD, PhD
Principal Investigator
Beijing Cancer Hospital
China: Ministry of Health
HD+DC-CIK
NCT01232062
August 2010
September 2014
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