Study of High-dose Chemotherapy (HDC) Combined With Adoptive Cellular Therapy With DC-CIK Cells in Triple Negative Breast Cancer Patients

Peking University Cancer Hospital & Institute

Status: Completed

Conditions: Neoplasm Metastasis; Breast Neoplasms

Study type: Observational

Funder types: Other

Identifiers

NCT01232062

HD+DC-CIK

Details and patient eligibility

About

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

Full 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.

Enrollment: 46 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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;
• 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;