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

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: NCT01232062
Recruitment Status : Completed
First Posted : November 2, 2010
Last Update Posted : July 23, 2015
Information provided by (Responsible Party):
Jun Ren, Beijing Cancer Hospital

Brief Summary:
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

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 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.

Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. response to chemotherapy [ Time Frame: 4months ]
    Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST).

Secondary Outcome Measures :
  1. 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.

  2. survival rates [ Time Frame: one-year ]
  3. clinical benefit response [ Time Frame: six months to one year ]
    clinical benefit response include CR,PR,SD

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   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;
  • 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;

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): NCT01232062

Beijing Cancer Hospital
Beijing, China, 100142
Sponsors and Collaborators
Beijing Cancer Hospital
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

Responsible Party: Jun Ren, Director, Beijing Cancer Hospital Identifier: NCT01232062     History of Changes
Other Study ID Numbers: HD+DC-CIK
First Posted: November 2, 2010    Key Record Dates
Last Update Posted: July 23, 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