Know Cancer

or
forgot password

A Phase II Randomized Study to Verify the Papaldo's Hypothesis : the Effectiveness of a Reduced Dosing of G-CSF in Chemotherapy-treated Patients With a Low to Moderate Risk of Febrile Neutropenia


Phase 2
N/A
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

A Phase II Randomized Study to Verify the Papaldo's Hypothesis : the Effectiveness of a Reduced Dosing of G-CSF in Chemotherapy-treated Patients With a Low to Moderate Risk of Febrile Neutropenia


Inclusion Criteria:



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

Exclusion Criteria:

Eligibility to receive reimbursed GCSF

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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)

Outcome Time Frame:

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

Safety Issue:

No

Authority:

Belgium: Ethics Committee

Study ID:

Institut Jules Bordet

NCT ID:

NCT01658956

Start Date:

July 2012

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • GCSF
  • Chemotherapy
  • Breast cancer
  • Prophylaxis
  • Breast Neoplasms
  • Neutropenia

Name

Location