NCT02539017

The Clinical Significance of Cellular Immune Adjuvant Therapy of Triple Negative Breast Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

As a special type of breast cancer, the triple negative breast cancer has the characteristics of high recurrence rate (2 years after surgery), high distant metastasis rate, poor prognosis and short survival time. No matter at home or abroad, the clinical researches of the triple negative breast cancer are mainly focused on finding new drugs and new treatment strategies in order to reduce its recurrence and distant metastasis rate. The DC/CIK cell immunotherapy combined with chemotherapy in the clinical study of metastatic triple negative breast cancer has already confirmed benefit. This study is based on the theory that the optimal timing of cellular immunity is while the host tumor load is under the smallest state. Put forward the hypothesis that the DC/CIK cell immunotherapy combined with chemotherapy may improve the disease-free survival and overall surviva after the triple negative breast cancer operation. The investigators intends to use the RCT, observing the clinical significance of cellular immune adjuvant therapy of triple negative breast cancer in 340 patients with TNBC. Do the safety evaluation of cellular immunity in the adjuvant treatment of breast cancer treatment, explore the clinical strategies for breast cancer immunotherapy.

Conditions

• Triple Negative Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Chemo	Epirubicin,75mg/m2,intravenous ,on day 1 of each 21 day cycle, 4 cycles Cyclophosphamide,0.6g/m2,intravenous, on day 1 of each 21 day cycle, 4 cycles Docetaxel,75mg/m2, intravenous, on day 1 of each 21 day cycle, 4 cycles
BIOLOGICAL	Immunotherapy	Immunotherapy with double dendritic cell (DC)and cytokine-induced killer (CIK) cell

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-09-01
• First posted: 2015-09-02
• Last updated: 2016-08-10

Locations

1 site across 1 country: China