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

Study of Chemotherapy Combined With Adoptive Cellular Therapy With Dendritic and Cytokine-induced Killer 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

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100142
    • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

female patients with metastatic breast cancer

Description

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;

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival	progression-free survivalis measured from the date therapy is initiated to the date of documented disease progression or death	six months to two year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical benefit response and overall survival	clinical benefit response include complete release(CR), partial release (PR), stable disease (SD).	six months to two year

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute
• Investigators: Principal Investigator: Jing Yu, MD, PhD, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: July 14, 2011
• First Submitted That Met QC Criteria: July 14, 2011
• First Posted (Estimate): July 15, 2011

Study Record Updates

• Last Update Posted (Estimate): July 22, 2015
• Last Update Submitted That Met QC Criteria: July 20, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Drug Therapy; breast neoplasm; Neoplasm Metastasis
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms by Site; Breast Diseases; Neoplastic Processes; Neoplasms; Breast Neoplasms; Neoplasm Metastasis; Triple Negative Breast Neoplasms
• Other Study ID Numbers: CTX+TSPA+CBP