Sponsored by UNC Lineberger Comprehensive Cancer Center

Phase	Quota	Distance
Phase N/A		Near

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at tissue and blood samples from women with locally advanced or metastatic breast cancer who are undergoing chemotherapy before surgery.

Study Start Date: December 1998

Estimated Completion Date: November 2022

Specialties: Obstetrics & Gynecology: Basic Science/Genetics,Breast,Gynecologic Oncology Oncology: Basic Science/Genetics,Breast,Diagnostics/Radiology Pathology: Cancer Biology,Molecular Path/Genetics

Interventions

• Other: biologic sample preservation procedure
• Procedure: biopsy
• Other: laboratory biomarker analysis

Inclusion criteria

• Histologically proven metastatic breast cancer with measurable or evaluable disease per investigator discretion.
• Patients must be 18 years of age or older. Women of child bearing potential must be practicing barrier or oral contraception for the duration of the study, or documented as surgically sterile or one year post-menopausal.
• ECOG performance status 0-2
• Cardiac function by MUGA with an EF > 45% or an echocardiogram that shows normal LV function.
• Serum Creatinine < 2.0 mg/dl.
• Hepatic transaminases (alanine aminotransferase (ALT) and aspartate aminotransferase (AST)) ≤3.0 times the upper limit of normal if no liver metastases or ≤5 times the upper limit of normal if liver metastases are present.
• Bilirubin no more than 2X normal.
• Seronegative for HIV.
• Negative for Hepatitis B surface antigen.
• Signed and dated informed consent.
• HLA A0201+ by DNA genotyping.
• Absolute neutrophil count greater than 1,500/mm3. Platelet count greater 100,000/mm3 and hemoglobin greater than or equal to 10
• 3+ expression of HER-2/neu from original pathology (diagnostic) tumor sample by IHC or 2+ expression by IHC with gene amplification by FISH.
• Patients will be eligible even if they have failed treatment for metastatic breast cancer with trastuzumab and a chemotherapy agent other than vinorelbine or if they have progressed within 12 months of receiving adjuvant chemotherapy using trastuzumab and a taxane.

Exclusion criteria

• Patients with any serious medical, cardiac, or psychiatric condition which, in the opinion of the investigator, would make the patient unsuitable for study participation or would impede probable compliance with the protocol.
• Patients with central nervous system metastases must have stable disease for at least 3 months prior to study entry.
• Patient is currently taking steroid medications. Systemic steroid treatment is not allowed.
• Patients that have failed prior therapy with vinorelbine + trastuzumab will not be eligible for therapy.
• Patient has received hormonal or cytotoxic chemotherapy within 14 days of apheresis and within 28-30 days prior to study treatment.

Study Locations And Contact Information

• Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill, Chapel Hill North Carolina
  Contact: Clinical Trials Office Lineberger Comprehensive Cancer Cente 877-668-0683
• Nash Heathcare, Rocky Mount North Carolina