Rajendra A Badwe, MS

CONTACT

Lead Sponsor

Dr Rajendra A. Badwe

Collaborators

Age

18 - 80 years

Sex

FEMALE

Healthy Volunteers

No

•1. Female subjects aged 18 years or older.
•2. Histologically and/or cytologically confirmed diagnosis of breast cancer. Clinical stages breast cancer: HER2 positive, T1 or T2 or T3, N0 or N1, resectable T4, or resectable N2, (all M0)
•3. Documentation of erbB-2 gene amplification by FISH (as defined by a ratio \>2.2) or chromogenic in situ hybridization (CISH, as defined by the manufacturer's kit instruction) or documentation of erbB-2-overexpression by IHC (defined as IHC3+, or IHC2+ with FISH or CISH confirmation) based on local laboratory.
•4. LVEF within institutional range of normal as measured by MUGA or ECHO.
•5. Screening laboratory values within the following parameters:
•1. Absolute neutrophil count (ANC) ≥1.5 x 109 /L (1500/mm3)
•2. Platelet count ≥100 x 109/L (100,000/mm3)
•3. Hemoglobin ≥9.0 g/dL (90 g/L)
•4. Serum creatinine ≤1.5 x upper limit of normal (ULN)
•5. Total bilirubin ≤1.5 x ULN (\<3 ULN if Gilbert's disease) 6Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)
•* 2.5 x ULN

•1. Bilateral breast cancer
•2. Active uncontrolled cardiac disease, including cardiomyopathy, CHF (New York Heart Association \[NYHA\] functional classification of ≥3), unstable angina, and myocardial infarction (within 12 months of study entry).
•3. Inadequately controlled hypertension (ie, systolic blood pressure \[BP\] \> 180 mm Hg or diastolic BP \> 100 mm Hg).
•4. Family history of congenital long or short QT syndrome, Brugada syndrome or QT/QTc interval \> 0.45 second or known history of QT/QTc prolongation or torsade de pointe (TdP).
•5. Significant chronic gastrointestinal disorder with diarrhea as a major symptom (eg, Crohn's disease, malabsorption, or grade ≥2 diarrhea of any etiology at baseline).
•6. Women who are pregnant, breast-feeding.