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

• Status: Terminated
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI); Susan G. Komen Breast Cancer Foundation
• Treatments: Trastuzumab; Vaccines; Vinblastine; Vinorelbine

Criteria

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count > 1,500/mm^3

• Platelet count > 100,000/mm^3

• Hematocrit > 33%

Hepatic

• Transaminases ≤ 3 times upper limit of normal

• Bilirubin ≤ 2 times normal

• Hepatitis B surface antigen negative

Renal

• Creatinine < 2.0 mg/dL

Cardiovascular

• 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

Other

• 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Prior biologic therapy allowed

Chemotherapy

• 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

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• Concurrent bisphosphonates for bone metastases allowed