NCT01658956

Brief Summary

The study aims to confirm that a reduced dosage of GCSF is effective in preventing febrile neutropenia among patients with breast cancer, treated with chemotherapy and presenting with a low to moderate risk of developing febrile neutropenia.

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
142

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Jul 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

Study Start

First participant enrolled

July 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

January 6, 2015

Status Verified

January 1, 2015

Enrollment Period

3 years

First QC Date

July 27, 2012

Last Update Submit

January 5, 2015

Conditions

Breast Cancer

Keywords

GCSFChemotherapyBreast cancerProphylaxis

Outcome Measures

Primary Outcomes (1)

  • Occurrence of a febrile neutropenic episode defined as fever (>=38.5°C once or >=38°C twice within 12 hours interval) and neutropenia (ANC < 0.5 IU)

    At the beginning of 2nd chemotherapy cycle, no more than 30 days after randomization

Secondary Outcomes (3)

  • Need for unplanned hospitalization

    At the beginning of second chemotherapy cycle, no more than 30 days after randomization

  • Complicated febrile neutropenic episode

    At the beginning of the second chemotherapy cycle, no more than 30 days after randomization

  • Mortality any cause

    30 days from randomization

Study Arms (2)

Subcutaneous GCSF 5 µg/kg days 8 and 12

EXPERIMENTAL

Prophylactic administration of GCSF on days 8 and 12 following chemotherapy

Drug: GCSF administration on days 8 and 12 after chemotherapy

No intervention

NO INTERVENTION

Interventions

GCSF administration on days 8 and 12 after chemotherapyDRUG
Subcutaneous GCSF 5 µg/kg days 8 and 12

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Breast cancer Chemotherapy administration (new line) Chemotherapy type : FEC, EC, AC, docetaxel containing regimen Chemotherapy setting : adjuvant or neoadjuvant

You may not qualify if:

  • Eligibility to receive reimbursed GCSF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Jules Bordet

Brussels, 1000, Belgium

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2012

First Posted

August 7, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

January 6, 2015

Record last verified: 2015-01

Locations

BE(1)