A Study of Pegylated Liposomal Doxorubicin and Cyclophosphamide in Her2-negative Stage I and II Breast Cancer Patients
NCT ID: NCT01210768
Last Updated: 2021-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
254 participants
INTERVENTIONAL
2010-06-30
2022-10-31
Brief Summary
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* 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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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EC
Cyclophosphamide,600 mg/m2 q3wk and Epirubicin,90 mg/m2 q3wk
Epirubicin+Cyclophosphamide
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.
LC
liposomal doxorubicin, 37.5 mg/m2 q3wk, and Cyclophosphamide,600 mg/m2 q3wk
liposomal-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.
Interventions
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Epirubicin+Cyclophosphamide
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.
liposomal-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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
70 Years
FEMALE
No
Sponsors
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TTY Biopharm
INDUSTRY
Responsible Party
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Principal Investigators
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Ming-Feng Hou, MD
Role: PRINCIPAL_INVESTIGATOR
Kaohsiung Medical University Chung-Ho Memorial Hospital
Locations
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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
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
Countries
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Other Identifiers
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TTYLD0914
Identifier Type: -
Identifier Source: org_study_id