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:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-24 @ 5:45 PM
NCT ID:
NCT01210768
Eligibility Criteria:
Inclusion Criteria:
* histologically confirmed invasive, but non-inflammatory, breast adenocarcinoma with stage I or II (if N0, T must be \>1cm) disease
* Her2-negative on fluorescence in situ hybridization (FISH) study
* performance status of ECOG 0, 1
* female, age between 20 and 70 years
* life expectancy of at least one year
* ability to understand and willingness to sign a written informed consent document
Exclusion Criteria:
* Her2 3+ over-expression on immunohistochemistry (IHC), or Her2 amplification on fluorescence in situ hybridization (FISH) study
* previous or current systemic malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ, unless there has been a disease-free interval of at least 5 years
* Patients who have received prior chemotherapy
* inadequate hematological function defined as absolute neutrophil count (ANC)less than 1,500/mm3, and platelets less than 100,000/mm3
* inadequate hepatic function defined as: serum bilirubin greater than 1.5 times the upper limit of normal range (ULN) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN
* inadequate renal function defined as serum creatinine greater than 1.5 times the ULN
* left ventricular ejection fraction (LVEF) \< 50% confirmed by multiple-gated acquisition (MUGA) scan or echocardiogram
* concomitant illness that might be aggregated by chemotherapy or interfere study assessment. For examples, active, non- controlled infection (such as hepatitis B and hepatitis C, HIV, infectious tuberculosis) or other active, non-controlled disease such as congestive heart failure, ischemic heart disease, uncontrolled hypertension or arrhythmia, unstable diabetes mellitus, and active peptic ulcer
* patients who are presence of liver cirrhosis or are HBV/HCV carrier
* participation in another clinical trial with any investigational drug within 30 days prior to entry
* pregnant or breast feeding women
* fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period and for three months following cessation of treatment
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT01210768
Study Brief:
Protocol Section:
NCT01210768