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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by TTY Biopharm
Sponsor:
Information provided by:
TTY Biopharm
ClinicalTrials.gov Identifier:
NCT01210768
First received: August 31, 2010
Last updated: June 4, 2013
Last verified: June 2013

August 31, 2010
June 4, 2013
June 2010
July 2018   (final data collection date for primary outcome measure)
Disease-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01210768 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Baseline and every 3 weeks during therapy ] [ Designated as safety issue: No ]
  • Safety profiles [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: At approximately of 5 years maximum FU ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Pegylated Liposomal Doxorubicin and Cyclophosphamide in Her2-negative Stage I and II Breast Cancer Patients
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • 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.
  • 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.
  • Active Comparator: EC
    Cyclophosphamide,600 mg/m2 q3wk and Epirubicin,90 mg/m2 q3wk
    Intervention: Drug: Epirubicin+Cyclophosphamide
  • Experimental: LC
    liposomal doxorubicin, 37.5 mg/m2 q3wk, and Cyclophosphamide,600 mg/m2 q3wk
    Intervention: Drug: liposomal-doxorubicin+Cyclophosphamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
254
August 2018
July 2018   (final data collection date for primary outcome measure)

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
Female
20 Years to 70 Years
No
Taiwan
 
NCT01210768
TTYLD0914
No
Gregory Liu/ Senior Clinical Manager, TTY Biopharm
TTY Biopharm
Not Provided
Principal Investigator: Ming-Feng Hou, MD Kaohsiung Medical University Chung-Ho Memorial Hospital
TTY Biopharm
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP