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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
254
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.
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.
Changhua Christian Hospital
Changhua, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
Chang-Gung Memorial Hospital, Linkou
Linkou District, Taiwan
Disease-free survival
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
Time frame: 5 years
Overall survival
Time frame: 5 years
Quality of life
Time frame: Baseline and every 3 weeks during therapy
Safety profiles
Incidence and severity of adverse event (neutropenia, palmar-plantar erythrodysesthesia, cardiac function, and secondary leukemia) by assessing the toxicities and tolerability
Time frame: 5 years
Survival correlation with biomarkers expression
Time frame: At approximately of 5 years maximum FU
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China Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan