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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2015-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Breast Neoplasms Neoplasm Metastasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No