NCT02491697

Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer

Randomized Controlled Trial Comparing Dendritic Cells Co-cultured With Cytokine-induced Killer Cells Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: The First People's Hospital of Changzhou · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The prognosis of advanced breast cancer does not improve much recently although varies of adjuvant drugs have been tried.Dendritic cells co-cultured with cytokine-induced killer cells(DC-CIK) immunotherapy has been proved to improve survival in several cancers, but its role in advanced breast cancer stains unclear. The purpose of this study is to evaluate the efficacy and safety of DC-CIK immunotherapy combined with capecitabine versus capecitabine monotherapy for the treatment of advanced breast cancer.

Detailed description

1.400 patients with advanced breast cancer should be definitively diagnosis based on histopathology, according to the 7th American Joint Committee on Cancer(AJCC) Cancer Staging Manual. 2.All patients will be randomly divided into group A（DC-CIK immunotherapy combined with capecitabine ) or group B（capecitabine monotherapy). 3.Patients in group A will receive 4 cycles of DC-CIK treatment (every 1 year) and capecitabine(continuous).Patients in group B will receive only capecitabine monotherapy(continuous) . 4.The response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	DC-CIK Immunotherapy	DC-CIK cells are used to treat advanced breast cancer with capecitabine.
DRUG	Capecitabine Monotherapy	All patients receive capecitabine monotherapy (2500 mg/m2 twice daily) for 2 weeks followed by a 1-week rest period.And the treatment is repeated every 3 weeks.

Timeline

• Start date: 2016-02-01
• Primary completion: 2030-08-01
• Completion: 2033-08-01
• First posted: 2015-07-08
• Last updated: 2016-02-23