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Completed

NCT Number: NCT01395056

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Beijing Cancer Hospital

Beijing, 100142, China

About this study

  • 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 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 .
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Official study title

Study of Chemotherapy Combined With Adoptive Cellular Therapy With Dendritic and Cytokine-induced Killer Cells in Triple Negative Breast Cancer Patients

Acronym: DCCIK

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Jul 15, 2011
Registry last updated
Jul 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.