A Study of Pegylated Liposomal Doxorubicin and Cyclophosphamide in Her2-negative Stage I and II Breast Cancer Patients
- Conditions
- Breast Cancer
- Interventions
- Drug: Epirubicin+CyclophosphamideDrug: liposomal-doxorubicin+Cyclophosphamide
- Registration Number
- NCT01210768
- Lead Sponsor
- TTY Biopharm
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 254
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EC Epirubicin+Cyclophosphamide Cyclophosphamide,600 mg/m2 q3wk and Epirubicin,90 mg/m2 q3wk LC liposomal-doxorubicin+Cyclophosphamide liposomal doxorubicin, 37.5 mg/m2 q3wk, and Cyclophosphamide,600 mg/m2 q3wk
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Overall survival 5 years Survival correlation with biomarkers expression At approximately of 5 years maximum FU Quality of life Baseline and every 3 weeks during therapy
Trial Locations
- Locations (9)
Changhua Christian Hospital
🇨🇳Changhua, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Chang-Gung Memorial Hospital, Linkou
🇨🇳Linkou, Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
🇨🇳Taipei, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan