A Study of Pegylated Liposomal Doxorubicin and Cyclophosphamide in Her2-negative Stage I and II Breast Cancer Patients
Primary Purpose
Breast Cancer
Status
Active
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Epirubicin+Cyclophosphamide
liposomal-doxorubicin+Cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Phase II, Pegylated Liposomal Doxorubicin, Adjuvant Chemotherapy, Breast Cancer
Eligibility Criteria
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
Sites / Locations
- Changhua Christian Hospital
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Kaohsiung Veterans General Hospital
- Chang-Gung Memorial Hospital, Linkou
- China Medical University Hospital
- Taichung Veterans General Hospital
- National Taiwan University Hospital
- Shin Kong Wu Ho-Su Memorial Hospital
- Taipei Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
EC
LC
Arm Description
Cyclophosphamide,600 mg/m2 q3wk and Epirubicin,90 mg/m2 q3wk
liposomal doxorubicin, 37.5 mg/m2 q3wk, and Cyclophosphamide,600 mg/m2 q3wk
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Overall survival
Quality of life
Safety profiles
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01210768
Brief Title
A Study of Pegylated Liposomal Doxorubicin and Cyclophosphamide in Her2-negative Stage I and II Breast Cancer Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2010 (undefined)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TTY Biopharm
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Phase II, Pegylated Liposomal Doxorubicin, Adjuvant Chemotherapy, Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
254 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EC
Arm Type
Active Comparator
Arm Description
Cyclophosphamide,600 mg/m2 q3wk and Epirubicin,90 mg/m2 q3wk
Arm Title
LC
Arm Type
Experimental
Arm Description
liposomal doxorubicin, 37.5 mg/m2 q3wk, and Cyclophosphamide,600 mg/m2 q3wk
Intervention Type
Drug
Intervention Name(s)
Epirubicin+Cyclophosphamide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
liposomal-doxorubicin+Cyclophosphamide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease-free survival
Description
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
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
5 years
Title
Quality of life
Time Frame
Baseline and every 3 weeks during therapy
Title
Safety profiles
Description
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
Title
Survival correlation with biomarkers expression
Time Frame
At approximately of 5 years maximum FU
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Feng Hou, MD
Organizational Affiliation
Kaohsiung Medical University Chung-Ho Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhua Christian Hospital
City
Changhua
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Chang-Gung Memorial Hospital, Linkou
City
Linkou
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
A Study of Pegylated Liposomal Doxorubicin and Cyclophosphamide in Her2-negative Stage I and II Breast Cancer Patients
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