Study of High-dose Chemotherapy (HDC) Combined With Adoptive Cellular Therapy With DC-CIK Cells in Triple Negative Breast Cancer Patients

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Study of High-dose Chemotherapy Combined With Adoptive Cellular Therapy With Dentritic and Cytokine-induced Killer Cells in Triple Negative Breast Cancer Patients

Conditions
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Breast Neoplasms, Neoplasm Metastasis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Failure to anthracycline and/or taxol chemotherapy; metastatic tumor is histologically confirmed by immunohistochemical staining to be ER-negative and PR-negative. FISH testing for her-2-negative; Metastatic tumor can not be removed through surgery procedure; Metastatic tumor measured by PET-CT scan is at least 1cm; An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; Normal cardiac, hepatic, renal and bone marrow functions; Life expectancy ≥3 months. Exclusion Criteria: Do not finish twice PET-CT scan; Central nervous system metastases; Serious or uncontrolled concurrent medical illness; History of other malignancies; Having been enrolled in some other clinal trials within a month;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response to chemotherapy | Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST). | 4months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression | Time to disease progression is measured from the date therapy is initiated to the date of documented disease progression. | six months to one year | 
| survival rates |  | one-year | 
| clinical benefit response | clinical benefit response include CR,PR,SD | six months to one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast neoplasm, Neoplasm Metastasis, Drug Therapy