Text Size

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

This study is currently recruiting participants.
Verified September 2010 by TTY Biopharm
Sponsor:
Information provided by:
TTY Biopharm
ClinicalTrials.gov Identifier:
NCT01210768
First received: August 31, 2010
Last updated: September 27, 2010
Last verified: September 2010
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
 Drug: Epirubicin+Cyclophosphamide
Drug: liposomal-doxorubicin+Cyclophosphamide
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by TTY Biopharm:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 254
Study Start Date: June 2010
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01210768

Locations
Taiwan
Changhua Christian Hospital Not yet recruiting
Changhua, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital Active, not recruiting
Kaohsiung, Taiwan
Kaohsiung Veterans General Hospital Not yet recruiting
Kaohsiung, Taiwan
Chang-Gung Memorial Hospital, Linkou Not yet recruiting
Linkou, Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan
Contact: Hwei-Chung Wang, MD     +886-4-22052121 ext 1639     whcym64@yahoo.com.tw    
Taichung Veterans General Hospital Not yet recruiting
Taichung, Taiwan
Taipei Veterans General Hospital Not yet recruiting
Taipei, Taiwan
National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan
Shin Kong Wu Ho-Su Memorial Hospital Not yet recruiting
Taipei, Taiwan
Sponsors and Collaborators
TTY Biopharm
Investigators
Principal Investigator: Ming-Feng Hou, MD Kaohsiung Medical University Chung-Ho Memorial Hospital
  More Information

No publications provided

Responsible Party: Gregory Liu/ Senior Clinical Manager, TTY Biopharm
ClinicalTrials.gov Identifier: NCT01210768     History of Changes
Other Study ID Numbers: TTYLD0914
Study First Received: August 31, 2010
Last Updated: September 27, 2010
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by TTY Biopharm:
Phase II
Pegylated Liposomal Doxorubicin
Adjuvant Chemotherapy
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Doxorubicin
Epirubicin
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on May 19, 2013