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

Sponsor

TTY Biopharm (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT01210768

Collaborator

(none)

254

Enrollment

Locations

Arms

149

Duration (Months)

28.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Epirubicin+Cyclophosphamide Drug: liposomal-doxorubicin+Cyclophosphamide	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

254 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2010

Anticipated Primary Completion Date :

Oct 31, 2022

Anticipated Study Completion Date :

Oct 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: EC Cyclophosphamide,600 mg/m2 q3wk and Epirubicin,90 mg/m2 q3wk	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.
Experimental: LC liposomal doxorubicin, 37.5 mg/m2 q3wk, and Cyclophosphamide,600 mg/m2 q3wk	Drug: 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.

Arm

Intervention/Treatment

Active Comparator: EC

Cyclophosphamide,600 mg/m2 q3wk and Epirubicin,90 mg/m2 q3wk

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.

Experimental: LC

liposomal doxorubicin, 37.5 mg/m2 q3wk, and Cyclophosphamide,600 mg/m2 q3wk

Drug: 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.

Outcome Measures

Primary Outcome Measures

Disease-free survival [5 years]
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 [5 years]
Quality of life [Baseline and every 3 weeks during therapy]
Safety profiles [5 years]
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 [At approximately of 5 years maximum FU]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	Changhua Christian Hospital	Changhua	Taiwan
2	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung	Taiwan
3	Kaohsiung Veterans General Hospital	Kaohsiung	Taiwan
4	Chang-Gung Memorial Hospital, Linkou	Linkou	Taiwan
5	China Medical University Hospital	Taichung	Taiwan
6	Taichung Veterans General Hospital	Taichung	Taiwan
7	National Taiwan University Hospital	Taipei	Taiwan
8	Shin Kong Wu Ho-Su Memorial Hospital	Taipei	Taiwan
9	Taipei Veterans General Hospital	Taipei	Taiwan