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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01395056

Acronym

DCCIK

Enrollment

Registered

2011-07-15

Start date

2011-07-31

Completion date

2015-06-30

Last updated

2015-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms, Neoplasm Metastasis

Keywords

breast neoplasm, Neoplasm Metastasis, Drug Therapy

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame	Description
progression-free survival	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

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

Countries

China

Outcome results