drugset / Trial / NCT00266110

Vaccine Therapy, Trastuzumab, and Vinorelbine in Treating Patients With Locally Recurrent or Metastatic Breast Cancer

NCT00266110

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Vaccines made from a person's white blood cells may help the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vaccine therapy together with trastuzumab and vinorelbine may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving vaccine therapy together with trastuzumab and vinorelbine works in treating patients with locally recurrent or metastatic breast cancer.

Timeline

Start
2005-12
Primary completion
2013-02
Completion
2017-10-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Trastuzumab Monoclonal antibody 4 mg/kg Intravenous
Subject Trastuzumab Monoclonal antibody 6 mg/kg Intravenous
Subject Vinorelbine Small molecule 25 mg/m2 Intravenous
Subject therapeutic autologous dendritic cells Vaccine 2e+07 cells Other
Background sargramostim Protein / enzyme biologic 250 ug/m2 Subcutaneous

Indications