drugset / Trial / NCT02539017

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

NCT02539017 ↗

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2015-11
Primary completion
2017-09
Completion
—

Outcome

Outcome not reported

Stopped: “because of safety problem, this trial was stopped in the hospital”

Drugs

EvaluationDrugModalityDoseRoute
Subject Immunotherapy Cell therapy — —
Subject cytokine-induced killer Cell therapy — —
Background Cyclophosphamide Other / unclassified 2 unknown Intravenous
Background Cyclophosphamide Other / unclassified 0.6 g Intravenous
Background Docetaxel Small molecule 75 mg/m2 Intravenous
Background Epirubicin Small molecule 75 mg/m2 Intravenous