Effectiveness of Reduced GCSF Dosing in Patients With a Low to Moderate Risk of Febrile Neutropenia (PAPALDO)

Free University of Brussels (ULB)

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer

Treatments: Drug: GCSF administration on days 8 and 12 after chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01658956

Institut Jules Bordet

Details and patient eligibility

About

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.

Enrollment: 142 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

Subcutaneous GCSF 5 µg/kg days 8 and 12

Experimental group

Description:

Prophylactic administration of GCSF on days 8 and 12 following chemotherapy

Treatment:

Drug: GCSF administration on days 8 and 12 after chemotherapy

No intervention

No Intervention group