Don't get left behind! The modernized is coming. Check it out now.
Say goodbye to!
The new site is coming soon - go to the modernized
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00088985
Recruitment Status : Terminated (Funding unavailable)
First Posted : August 5, 2004
Results First Posted : May 9, 2017
Last Update Posted : June 20, 2017
National Cancer Institute (NCI)
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Brief Summary:

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with monoclonal antibody therapy and chemotherapy 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 women with locally recurrent or metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: therapeutic autologous dendritic cells Biological: trastuzumab Drug: vinorelbine ditartrate Phase 2

Detailed Description:



  • Determine the efficacy of multiepitope autologous dendritic cell vaccine, trastuzumab (Herceptin^®), and vinorelbine by measuring the change in the largest dimension of metastatic lesions, in women with locally recurrent or metastatic breast cancer that does not overexpress human epidermal growth factor receptor 2 (HER2)/neu.


  • Determine the ability of this regimen to induce functional antigen-specific T cells in these patients by measuring ex-vivo antigen-specific T-cell activity against peptide-pulsed dendritic cells and tumor targets by tetramer staining and intracellular cytokine assays.


  • Autologous dendritic cell mobilization and harvest: All patients undergo autologous dendritic cell mobilization with filgrastim (G-CSF) and/or sargramostim (GM-CSF) subcutaneously daily for 4 days followed by apheresis. Mobilized peripheral blood is processed for the production of dendritic cells by cluster of differentiation (CD)34-positive cell selection. The dendritic cells are expanded and then pulsed with E75 and E90 peptides.
  • Treatment: Patients receive vinorelbine IV over 6-10 minutes and trastuzumab (Herceptin ^®) IV over 90 minutes on day 1. Patients also receive autologous dendritic cells pulsed with E75 and E90 peptides subcutaneously over 2-5 minutes on day 1*. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Note: *If treatment is given locally, the vaccine therapy will be given at University of North Carolina (UNC) -Chapel Hill the following day.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial Evaluating The Efficacy Of A Multiepitope Dendritic Cell Vaccine Given With Trastuzumab And Vinorelbine For The Treatment Of Women With Metastatic Breast Cancer That Express HLA-A0201
Study Start Date : January 2004
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Dendritic Cell Vaccine
Dendritic Cells: Dosage: 20 x 106 dendritic cells (DCs) given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly
Biological: therapeutic autologous dendritic cells
10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection

Biological: trastuzumab
4 mg/kg intravenously, every 14 days

Drug: vinorelbine ditartrate
Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days

Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 6 months following treatment ]

    Response measured by Response Evaluation Criteria In Solid Tumors (RECIST), (Complete Response + Partial Response)

    Complete Response (CR)- Disappearance of all target lesions

    Partial Response (PR)-at least a 30% decrease in the longest diameters of target lesions, taking as reference the baseline longest diameter.

Secondary Outcome Measures :
  1. Immune Response [ Time Frame: 3 months following treatment ]
    Measured by intracellular cytokine staining for Interferon-gamma (INFgamma) and cluster of differentiation (CD107) up regulation and tetramer. A fourfold increase in the number of cluster of differentiation (CD8+) tetramers comparing prevaccine with peak postvaccine values indicated an immune response to the therapy.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed breast cancer

    • Locally recurrent or metastatic disease
  • HLA-A0201 positive by DNA genotyping
  • HER2/neu expression at least 1+ by immunohistochemistry of tumor sample
  • Central Nervous System (CNS) metastases allowed provided on therapy for 3 months and stable
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Female

Menopausal status

  • Not specified

Performance status

  • Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy

  • Not specified


  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Hematocrit > 33%


  • Transaminases ≤ 3 times upper limit of normal
  • Bilirubin ≤ 2 times normal
  • Hepatitis B surface antigen negative


  • Creatinine < 2.0 mg/dL


  • Ejection fraction > 45% by multigated acquisition scan (MUGA) OR
  • Left ventricular function normal by echocardiogram
  • No serious cardiac condition that would preclude study participation or compliance


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No serious medical or psychiatric condition that would preclude study participation or compliance


Biologic therapy

  • Prior biologic therapy allowed


  • More than 30 days since prior cytotoxic chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • More than 30 days since prior hormonal therapy
  • No concurrent hormonal therapy
  • No concurrent systemic steroids


  • Not specified


  • Not specified


  • Concurrent bisphosphonates for bone metastases allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00088985

Layout table for location information
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Susan G. Komen Breast Cancer Foundation
Layout table for investigator information
Study Chair: Jonathan S. Serody, MD UNC Lineberger Comprehensive Cancer Center
Additional Information:
Layout table for additonal information
Responsible Party: UNC Lineberger Comprehensive Cancer Center Identifier: NCT00088985    
Other Study ID Numbers: LCCC 0310
P50CA058223 ( U.S. NIH Grant/Contract )
R21CA105837 ( U.S. NIH Grant/Contract )
KG100307 ( Other Grant/Funding Number: Susan G Komen for the Cure )
First Posted: August 5, 2004    Key Record Dates
Results First Posted: May 9, 2017
Last Update Posted: June 20, 2017
Last Verified: May 2017
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
recurrent breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action