Status:
UNKNOWN
A Study of Pegylated Liposomal Doxorubicin and Cyclophosphamide in Her2-negative Stage I and II Breast Cancer Patients
Lead Sponsor:
TTY Biopharm
Conditions:
Breast Cancer
Eligibility:
FEMALE
20-70 years
Phase:
PHASE2
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 objec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2022
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT01210768
Start Date
June 1 2010
End Date
October 31 2022
Last Update
November 23 2021
Active Locations (9)
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1
Changhua Christian Hospital
Changhua, Taiwan
2
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
3
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
4
Chang-Gung Memorial Hospital, Linkou
Linkou District, Taiwan