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


N/A
18 Years
80 Years
Open (Enrolling)
Female
Breast Neoplasms, Neoplasm Metastasis

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Trial Information

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


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.


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;

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

progression-free survival

Outcome Description:

progression-free survivalis measured from the date therapy is initiated to the date of documented disease progression or death

Outcome Time Frame:

six months to two year

Safety Issue:

Yes

Principal Investigator

Jing Yu, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beijing Cancer Hospital

Authority:

China: Ministry of Health

Study ID:

CTX+TSPA+CBP

NCT ID:

NCT01395056

Start Date:

July 2011

Completion Date:

December 2014

Related Keywords:

  • Breast Neoplasms
  • Neoplasm Metastasis
  • breast neoplasm
  • Neoplasm Metastasis
  • Drug Therapy
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis

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