NCT01571518

Brief Summary

After resection of lymph node positive breast cancer, the injection duration and timing of Granulocyte-colony stimulating factor (G-CSF) could affect the neutropenia with TAC (Taxotere, Adriamycin, cyclophosphamide) chemotherapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

April 5, 2012

Status Verified

April 1, 2012

Enrollment Period

1.5 years

First QC Date

March 29, 2012

Last Update Submit

April 3, 2012

Conditions

Neutropenia

Keywords

G-CSFneutropeniaTAC

Outcome Measures

Primary Outcomes (1)

  • frequency of neutropenia

    during the 1 cycle (21days) of ajuvant chemotherapy with TAC, record the frequency of neutropenia aftr using G-CSF (Leucostim)

    Change from Baseline in neutrophil count at 21days

Study Arms (2)

early injection

EXPERIMENTAL

injection of G-CSF (leukostim)5㎍/kg from day 2 of TAC chemotherapy

Drug: late leukostim

late injection

SHAM COMPARATOR

injection of G-CSF (leukostim)5㎍/kg from day 5 of TAC chemotherapy

Drug: early leukostim

Interventions

late leukostimDRUG

injection of G-CSF (leukostim)5㎍/kg from day 5 of TAC chemotherapy

Also known as: 5leuko
early injection
early leukostimDRUG

injection of G-CSF (leukostim)5㎍/kg from day 2 of TAC chemotherapy

Also known as: 2leuko
late injection

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary invasive breast carcinoma with lymph node positive with curative surgery with TAC chemotherapy

You may not qualify if:

  • pregnancy,
  • cardiovascualr disease,
  • abnormal renal function,
  • hematologic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soonchunhyang university Puchun Hospital

Puchun, South Korea

Location

Related Publications (1)

  • Chan A, Fu WH, Shih V, Coyuco JC, Tan SH, Ng R. Impact of colony-stimulating factors to reduce febrile neutropenic events in breast cancer patients receiving docetaxel plus cyclophosphamide chemotherapy. Support Care Cancer. 2011 Apr;19(4):497-504. doi: 10.1007/s00520-010-0843-8. Epub 2010 Mar 17.

    PMID: 20232087RESULT

MeSH Terms

Conditions

Neutropenia

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Officials

  • Chul Wan Lim, MD,PhD

    Soonchunhyang U Puchun Hospital

    STUDY CHAIR

Central Study Contacts

Chul Wan Lim, M.D., Ph.D

CONTACT

82-32-621-5114cylim@soonchunhyang.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 29, 2012

First Posted

April 5, 2012

Study Start

April 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

April 5, 2012

Record last verified: 2012-04

Locations

KR(1)