A Study of Pegylated Liposomal Doxorubicin and Cyclophosphamide in Her2-negative Stage I and II Breast Cancer Patients

TTY Biopharm

Status and phase

Unknown

Phase 2

Conditions

Breast Cancer

Treatments

Drug: liposomal-doxorubicin+Cyclophosphamide

Drug: Epirubicin+Cyclophosphamide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01210768

TTYLD0914

Details and patient eligibility

About

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.

Enrollment

254 estimated patients

Sex

Female

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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