Study of Chemotherapy With Adoptive Cellular Therapy With DC-CIK Cells in Triple Negative Breast Cancer Patients (DCCIK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01395056
Recruitment Status : Completed
First Posted : July 15, 2011
Last Update Posted : July 22, 2015
Information provided by (Responsible Party):
Jun Ren, Beijing Cancer Hospital

Brief Summary:
To access the effectiveness of cyclophosphamide combined thiotepa and carboplatin chemotherapy combined with adoptive cellular therapy with dendritic and cytokine-induced killer cells in triple negative metastatic breast cancer patients

Condition or disease
Breast Neoplasms Neoplasm Metastasis

Detailed Description:
  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 cyclophosphamide combined thiotepa and carboplatin chemotherapy and cellular therapy.Cellular therapy consisting of one cycle of chemotherapy followed by an apheresis and ex vivo cultures to generate DC and CIK, followed by low-dose Oral Cyclophosphamide .
  3. 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.

Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Chemotherapy Combined With Adoptive Cellular Therapy With Dendritic and Cytokine-induced Killer Cells in Triple Negative Breast Cancer Patients
Study Start Date : July 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. progression-free survival [ Time Frame: six months to two year ]
    progression-free survivalis measured from the date therapy is initiated to the date of documented disease progression or death

Secondary Outcome Measures :
  1. clinical benefit response and overall survival [ Time Frame: six months to two year ]
    clinical benefit response include complete release(CR), partial release (PR), stable disease (SD).

Biospecimen Retention:   None Retained
about 4ml peripheral vein blood,paraffin section on metastatic tissue,

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
female patients with metastatic breast cancer

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;
  • 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:

  • 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;

Information from the National Library of Medicine

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 identifier (NCT number): NCT01395056

Beijing Cancer Hospital
Beijing, China, 100142
Sponsors and Collaborators
Beijing Cancer Hospital
Principal Investigator: Jing Yu, MD, PhD Beijing Cancer Hospital

Responsible Party: Jun Ren, Director of the Medical Oncology, Beijing Cancer Hospital Identifier: NCT01395056     History of Changes
Other Study ID Numbers: CTX+TSPA+CBP
First Posted: July 15, 2011    Key Record Dates
Last Update Posted: July 22, 2015
Last Verified: July 2015

Keywords provided by Jun Ren, Beijing Cancer Hospital:
breast neoplasm
Neoplasm Metastasis
Drug Therapy

Additional relevant MeSH terms:
Neoplasm Metastasis
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases