Vandetanib in Treating Patients with Breast Cancer

Inclusion Criteria

• Patients with core breast biopsy that, on pathology review, demonstrates invasive breast cancer and are determined to need surgical excision of the lesion; all subtypes of invasive breast cancer will be enrolled; core biopsy specimens of enrolled patients will be stained for RET by immunohistochemistry and scored, however, patients will not be excluded according to RET expression
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• Life expectancy of greater than 6 months
• Ability and willingness to provide informed consent to participate in this study

Exclusion Criteria

• Prolonged QT interval (corrected QT interval [QTc] > 480 milliseconds) on screening electrocardiogram (EKG) or congenital long QT syndrome
• Any concomitant medications that are known to be associated with Torsades de Pointes or QT elongation
• Hypertension not controlled by medical therapy (systolic blood pressure [BP] greater than 160 millimeters of mercury [mmHg] or diastolic blood pressure great than 100 mmHg)
• Patients taking metformin or digoxin
• History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (Common Terminology Criteria for Adverse Events [CTCAE] grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia; patients with atrial fibrillation controlled by medication are permitted
• Significant cardiac event (e.g., myocardial infarction), superior vena cava syndrome, New York Heart Association (NYHA) classification of heart disease >= 2 within 12 weeks, or presence of cardiac disease that in the opinion of the investigator increases the risk of ventricular arrhythmia
• Serum calcium or magnesium outside the institutional range of normal
• Serum potassium < 4.0 mmol/L or above 5.0 mmol/L
• Creatinine clearance < 50 ml/min
• Prothrombin time (PT) > 12 seconds or partial thromboplastin time (PTT) > 31 seconds
• Platelet count of < 100,000
• Serum bilirubin greater than 1.5 mg/dl
• Alanine aminotransferase (ALT) > 50 U/L or aspartate aminotransferase (AST) > 65 U/L
• Alkaline phosphatase (ALP) > 250 U/L
• Any cytotoxic treatments, such as neoadjuvant chemotherapy, planned before subsequent surgical procedure
• Previous exposure to vandetanib
• Previous enrollment or randomization in this study
• Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and staff at University of Iowa Hospitals and Clinics [UIHC])
• Previous or current malignancies of other histologies within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin
• Patients who have received prior surgical site radiation
• Patients on cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors or inducers
• Inability to test core biopsy for study markers
• Pregnancy or lactation at the time of study entry (note: pregnancy testing must be performed within 2 weeks prior to randomization according to institutional standards for women of childbearing potential)