CClinicalTrials.gg
Sign In
Status unknownNCT01210768Updated Nov 23, 2021

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

A Phase 2 interventional study of Epirubicin+Cyclophosphamide and liposomal-doxorubicin+Cyclophosphamide in Breast Cancer, sponsored by TTY Biopharm. Status unknown at 9 sites in Taiwan. Open to female participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-11-23.

Sponsored by TTY Biopharm · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
254
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
Female
01

Study 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.
02

Conditions studied

  • Breast Cancer

Browse trials for

Keywords

  • Phase II
  • Pegylated Liposomal Doxorubicin
  • Adjuvant Chemotherapy
  • Breast Cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 254 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

TTY Biopharm is the lead sponsor of 14 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
254 participants (estimated)

Study arms

  • Active comparator
    EC

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

    Drug: Epirubicin+Cyclophosphamide

  • Experimental
    LC

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

    Drug: liposomal-doxorubicin+Cyclophosphamide

Interventions

  • DrugEpirubicin+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.

  • Drugliposomal-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.

06

What researchers measure

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

    Time frame: 5 years

Secondary outcomes

  1. Overall survival

    Time frame: 5 years

  2. Quality of life

    Time frame: Baseline and every 3 weeks during therapy

  3. Safety profiles

    Incidence and severity of adverse event (neutropenia, palmar-plantar erythrodysesthesia, cardiac function, and secondary leukemia) by assessing the toxicities and tolerability

    Time frame: 5 years

  4. Survival correlation with biomarkers expression

    Time frame: At approximately of 5 years maximum FU

07

Study locations

9 sites
  • Changhua Christian Hospital
    Changhua, Taiwan
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
    Kaohsiung, Taiwan
  • Kaohsiung Veterans General Hospital
    Kaohsiung, Taiwan
  • Chang-Gung Memorial Hospital, Linkou
    Linkou, Taiwan
  • China Medical University Hospital
    Taichung, Taiwan
  • Taichung Veterans General Hospital
    Taichung, Taiwan
  • National Taiwan University Hospital
    Taipei, Taiwan
  • Shin Kong Wu Ho-Su Memorial Hospital
    Taipei, Taiwan
  • Taipei Veterans General Hospital
    Taipei, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01210768
Lead sponsor
TTY Biopharm
Responsible party
Sponsor
First posted
Sep 28, 2010
Start date
Jun 2010
Primary completion
Oct 31, 2022 (estimated)
Completion
Oct 31, 2022 (estimated)
Last update
Nov 23, 2021

Study contacts

Ming-Feng Hou, MD
principal investigator · Kaohsiung Medical University Chung-Ho Memorial Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Breast Neoplasms→

Other studies from this sponsor

TTY Biopharm

Start the discussion