A Phase II Randomized Study of Pegylated Liposomal Doxorubicin, Cyclophosphamide Versus Epirubicin-Cyclophosphamide as Adjuvant Chemotherapy in Her2-negative Stage I and II Breast Cancer Patients
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