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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


Phase 2
20 Years
70 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Outcome Description:

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

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Ming-Feng Hou, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Kaohsiung Medical University Chung-Ho Memorial Hospital

Authority:

Taiwan : Food and Drug Administration

Study ID:

TTYLD0914

NCT ID:

NCT01210768

Start Date:

June 2010

Completion Date:

August 2018

Related Keywords:

  • Breast Cancer
  • Phase II
  • Pegylated Liposomal Doxorubicin
  • Adjuvant Chemotherapy
  • Breast Cancer
  • Breast Neoplasms

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