Prophylactic Use of PEG-rhG-CSF in Medium-high Risk of FN in Chemotherapy of Breast Cancer

University of Chinese Academy Sciences

Status: Unknown

Conditions: Febrile Neutropenia

Treatments: Drug: PEGCSF second level prophylactic use; Drug: PEGCSF first level prophylactic use

Study type: Observational

Funder types: Other

Identifiers

NCT03618810

RWS-PEGCSF

Details and patient eligibility

About

This clinical study is a multiple center, registering and real-world conditional research. The breast cancer patients planning for chemotherapy evaluated with medium-high risk of febrile neutropenia (FN) are recruited, receiving the first level prophylactic use of PEG-rhG-CSF or the second level prophylactic use of PEG-rhG-CSF in at least two cycles of chemotherapy according to real-world clinical judgement and choice by physicians in local cancer center. Comparing real conditional-FN rate, FN-caused hospitalization rate and antibiotic use rate, direct/indirect medical cost.

Full description

The breast cancer patients planning for neo-adjuvant/adjuvant chemotherapy evaluated with medium-high risk of febrile neutropenia (FN) according to NCCN and ASCO guideline are recruited, receiving the first level prophylactic use of PEG-rhG-CSF or the second level prophylactic use of PEG-rhG-CSF according to real-world clinical judgement and choice by physicians in local cancer center for at least two cycles of chemotherapy. The primary outcome is FN rate, the second outcomes are rate of 3-4 grade decrease of ANC, FN-caused hospitalization, FN-caused antibiotic use rate, rate of reduction of chemotherapy dose, delay of chemotherapy, safety and pharmacoeconomics.

Enrollment: 2,000 estimated patients

Sex: Female

Ages: 13 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. provision of informed consent
2. stage I-III, invasive breast cancer
3. accept at least 4 cycles of chemotherapy
4. ECOG score 0-2
5. with medium-high risk of FN according to researchers

Exclusion criteria

1. accepted stem cell or bone marrow transplant
2. undergoing any other clinical trial
3. uncontrolled infection, temperature≥38℃
4. per-week scheme chemotherapy
5. concurrent with radiotherapy
6. allergic conditions
7. sever organ dysfunction
8. uncontrolled diabetes

Trial design

2,000 participants in 2 patient groups

PEGCSF first level prophylactic use

Description:

The first level prophylactic use of PEG-rhG-CSF. The Prophylactic use of PEG-rhG-CSF in all cycles of chemotherapy.

Treatment:

Drug: PEGCSF first level prophylactic use

PEGCSF second level prophylactic use

Description:

The second level prophylactic use of PEG-rhG-CSF. The Prophylactic use of PEG-rhG-CSF in the next cycle until FN or 4 grade neutropenia happened.

Treatment:

Drug: PEGCSF second level prophylactic use