Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT01785420
Eligibility Criteria:
Inclusion Criteria:a.
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
Exclusion Criteria:
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01785420
Study Brief:
Protocol Section:
NCT01785420