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

NCT01210768 | Unknown Phase 2

• 1 other identifier: TTYLD0914
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 9

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.

Conditions

Breast Cancer

Keywords

Phase II; Pegylated Liposomal Doxorubicin; Adjuvant Chemotherapy; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  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

  5 years

Secondary Outcomes (4)

• Overall survival

  5 years

• Quality of life

  Baseline and every 3 weeks during therapy

• Safety profiles

  5 years

• Survival correlation with biomarkers expression

  At approximately of 5 years maximum FU

Study Arms (2)

EC

ACTIVE COMPARATOR

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

Drug: Epirubicin+Cyclophosphamide

LC

EXPERIMENTAL

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

Drug: liposomal-doxorubicin+Cyclophosphamide

Interventions

Epirubicin+Cyclophosphamide DRUG

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.

EC

liposomal-doxorubicin+Cyclophosphamide DRUG

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.

LC

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TTY Biopharm: lead

Study Sites (9)

Changhua Christian Hospital

Changhua, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Location

Chang-Gung Memorial Hospital, Linkou

Linkou District, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

EC regimen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ming-Feng Hou, MD

  Kaohsiung Medical University Chung-Ho Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: September 28, 2010
• Study Start: June 1, 2010
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: November 23, 2021

Record last verified: 2021-11

Locations

TW (9)