Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Dr Rajendra A. Badwe
With
Tata Memorial Hospital
Age
18–80
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Pre Operative Trastuzumab in Operable Breast Cancer
