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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01210768
Other study ID # TTYLD0914
Secondary ID
Status Recruiting
Phase Phase 2
First received August 31, 2010
Last updated February 6, 2017
Start date June 2010
Est. completion date August 2018

Study information

Verified date February 2017
Source TTY Biopharm
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 254
Est. completion date August 2018
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
Taiwan Changhua Christian Hospital Changhua
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung
Taiwan Kaohsiung Veterans General Hospital Kaohsiung
Taiwan Chang-Gung Memorial Hospital, Linkou Linkou
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

Sponsors (1)

Lead Sponsor Collaborator
TTY Biopharm

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 5 years
Secondary Overall survival 5 years
Secondary Quality of life Baseline and every 3 weeks during therapy
Secondary Safety profiles Incidence and severity of adverse event (neutropenia, palmar-plantar erythrodysesthesia, cardiac function, and secondary leukemia) by assessing the toxicities and tolerability 5 years
Secondary Survival correlation with biomarkers expression At approximately of 5 years maximum FU
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