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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
Sponsor:
Information provided by (Responsible Party):
Jun Ren, Beijing Cancer Hospital

October 29, 2010
November 2, 2010
July 23, 2015
August 2010
May 2011   (Final data collection date for primary outcome measure)
response to chemotherapy [ Time Frame: 4months ]
Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST).
Same as current
Complete list of historical versions of study NCT01232062 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Study of High-dose Chemotherapy (HDC) Combined With Adoptive Cellular Therapy With DC-CIK Cells in Triple Negative Breast Cancer Patients
Study of High-dose Chemotherapy Combined With Adoptive Cellular Therapy With Dentritic and Cytokine-induced Killer 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
  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
Not Provided
Retention:   None Retained
Description:
about 4ml peripheral vein blood,paraffin section on metastatic tissue,
Probability Sample
female patients with metastatic breast cancer
  • Breast Neoplasms
  • Neoplasm Metastasis
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
40
October 2013
May 2011   (Final data collection date for primary outcome measure)

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;
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01232062
HD+DC-CIK
Yes
Not Provided
Not Provided
Jun Ren, Beijing Cancer Hospital
Beijing Cancer Hospital
Not Provided
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
Beijing Cancer Hospital
July 2015