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


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

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Trial Information

Study of High-dose Chemotherapy Combined With Adoptive Cellular Therapy With Dentritic 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 HDC and cellular therapy.HDC and
cellular therapy consisting of one cycle of HDC followed by an apheresis and ex vivo
cultures to generate DC and CIK. DC-CIK infusions were given to each patient, followed
by two cycles HDC, plus low-dose Oral Cyclophosphamide.

3. PET-CT scans were done on each patients at baseline and after chemotherapy. 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;

- Metastatic tumor measured by PET-CT scan is at least 1cm;

- 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:

- Do not finish twice PET-CT scan;

- 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: Retrospective

Outcome Measure:

response to chemotherapy

Outcome Description:

Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST).

Outcome Time Frame:

4months

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:

HD+DC-CIK

NCT ID:

NCT01232062

Start Date:

August 2010

Completion Date:

September 2014

Related Keywords:

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

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