Breast Cancer
Conditions
Keywords
Phase II, Pegylated Liposomal Doxorubicin, Adjuvant Chemotherapy, Breast Cancer
Brief summary
Primary objective: * To evaluate the disease-free survival (DFS) in the two randomized arms after therapy with LC vs. EC in chemo-naive Her2-patients with stage I or II breast cancer Secondary objectives: * To assess the overall survival (OS) * To establish the safety profile by assessing the toxicities and tolerability * To assess the quality of life (QoL) * To evaluate survival correlation with biomarkers expression.
Interventions
Cyclophosphamide 600 mg/m2 infusion followed by epirubicin 90 mg/m2 infusion on Day 1 in each 21-day treatment cycle. Treatment will be repeated for 4 cycles in the EC arm.
DRUGliposomal-doxorubicin+Cyclophosphamide
Cyclophosphamide 600 mg/m2 infusion followed by pegylated liposomal-doxorubicin 37.5mg/m2 infusion on Day 1 in each 21-day treatment cycle. Treatment will be repeated for 5 cycles in the LC arm.
Sponsors
TTY Biopharm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | 5 years | To evaluate the disease-free survival (DFS) in the two randomized arms after therapy with LC vs. EC in chemo-naive Her2-patients with stage I or II breast cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 5 years | — |
| Quality of life | Baseline and every 3 weeks during therapy | — |
| Safety profiles | 5 years | Incidence and severity of adverse event (neutropenia, palmar-plantar erythrodysesthesia, cardiac function, and secondary leukemia) by assessing the toxicities and tolerability |
| Survival correlation with biomarkers expression | At approximately of 5 years maximum FU | — |
Countries
Taiwan
Outcome results
None listed