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

Completed

• Conditions: Breast Neoplasms; Neoplasm Metastasis

• Registration Number: NCT01232062
• Lead Sponsor: Peking University Cancer Hospital & Institute

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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-10-29
• Study First Submitted QC: 2010-11-01
• Study First Posted: 2010-11-02
• Primary Completion: 2011-05
• Study Completion: 2013-10
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-22
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
response to chemotherapy	4months	Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST).

Secondary Outcome Measures

Name	Time	Method
clinical benefit response	six months to one year	clinical benefit response include CR,PR,SD
Time to disease progression	six months to one year	Time to disease progression is measured from the date therapy is initiated to the date of documented disease progression.
survival rates	one-year

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, China