Clinical trial NCT01232062: Study of High-dose Chemotherapy (HDC) Combined With Adoptive Cellular Therapy With DC-CIK Cells in Triple Negative Breast Cancer Patients
Official title: Study of High-dose Chemotherapy Combined With Adoptive Cellular Therapy With Dentritic and Cytokine-induced Killer Cells in Triple Negative Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Neoplasm Metastasis
Keywords: breast neoplasm
Neoplasm Metastasis
Drug Therapy
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2010-11-02
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: female patients with metastatic breast cancer

Brief summary: To access the effectiveness of High-dose Cyclophosphamide Combined Chemotherapy combined with adoptive cellular therapy with dentritic 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 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.

Eligibility criteria: 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;

Primary outcomes:
measure: response to chemotherapy
timeFrame: 4months
Secondary outcomes:
measure: Time to disease progression
timeFrame: six months to one year
measure: survival rates
timeFrame: one-year
measure: clinical benefit response
timeFrame: six months to one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: JING YU, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Cancer Hospital & Institute
name: CHAO YING WANG, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Cancer Hospital & Institute
name: JUN REN, MD, PhD
role: STUDY_CHAIR
affiliation: Bei jing Cancer Hospital
name: YU LIN ZHU, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Cancer Hospital & Institute
name: Jie Zhang, MD.
role: PRINCIPAL_INVESTIGATOR
References: