Clinical trial NCT01210768: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Phase II
Pegylated Liposomal Doxorubicin
Adjuvant Chemotherapy
Breast Cancer
Lead sponsor: TTY Biopharm
Sponsor class: INDUSTRY
First posted: 2010-09-28
Enrollment: 254
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Disease-free survival
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
measure: Quality of life
timeFrame: Baseline and every 3 weeks during therapy
measure: Safety profiles
timeFrame: 5 years
measure: Survival correlation with biomarkers expression
timeFrame: At approximately of 5 years maximum FU
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Linkou
country: Taiwan
facility: Chang-Gung Memorial Hospital, Linkou
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Ming-Feng Hou, MD
role: PRINCIPAL_INVESTIGATOR
References: