Efficacy and Safety of 4.5mg PEG-rhG-CSF Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer

Phase 4

Completed

• Conditions: Breast Cancer; Neutropenia
• Interventions: Drug: PEG-rhG-CSF

• Registration Number: NCT04009941
• Lead Sponsor: Peking University

Brief Summary

This is a prospective, single-center, single-arm clinical study, to evaluate the clinical efficacy, safety and tolerance of patients with early breast cancer receiving ddEC adjuvant chemotherapy, accepting PEG-rhG-CSF as primary prevention of neutropenia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-30
• Study First Submitted QC: 2019-07-03
• Study First Posted: 2019-07-08
• Study Start: 2019-08-01
• Primary Completion: 2020-01-18
• Study Completion: 2020-01-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-26
• Last Update Posted: 2020-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 104

Inclusion Criteria

• Breast cancer patients in need for adjuvant chemotherapy confirmed by histopathology, whom should accept ddEC regimen.
• ECOG<=1
• Expected survival is greater than 6 months
• Qualified for chemotherapy，WBC>=3*109/L, ANC>=1.5*109/L, Hb>=80g/L, PLT>=80*109/L. With no bleeding tendency or systemic hematology disorder symptoms.
• No obvious EKG abnormality, no obvious cardiac dysfunction, and normal left ventricular ejection fraction.
• Liver function, ALT and AST should less than 2.5 times of the upper limit.
• Renal function, Cr and BUN should less than 1.5 times of the upper limit.
• Subjects voluntarily participate in this study and sign informed consent.

Exclusion Criteria

• Total amount of doxorubicin used in previous chemotherapy>240mg/m2, or epirubicin>360mg/m2
• Has received hematopoietic stem cell transplantation or bone marrow transplantation
• Other drugs are currently in clinical trials
• There are currently hard-to-control infections, body temperature is higher than 38 degrees.
• Received PEG-rhG-CSF treatment before enrollment
• Received chemotherapy in 4 weeks before enrollment
• Patients with any visceral metastasis
• Patients with severe heart, kidney, liver or any other important organs chronic diseases
• Patients with severe uncontrolled diabetes
• Patients with allergic diseases, or allergies to this product or other biological products derived from genetically engineered e. coli
• Suspected or real drug users, substance abusers, alcoholics
• Pregnant or lactating women
• Severe mental or neurological disorders that affect informed consent and adverse reactions described or observed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEG-rhG-CSF	PEG-rhG-CSF	Patients with breast cancer who were treated with intensive chemotherapy received PEG-rhG-CSF.

Primary Outcome Measures

Name	Time	Method
RDI for each EC chemotherapy	60 days after the first chemotherapy	Ratio of actual dose intensity to standard dose intensity
Chemotherapeutic dose adjustment due to neutropenia	60 days after the first chemotherapy	percentage of dose decreasing due to neutropenia
overall completion rate of chemotherapy	60 days after the first chemotherapy	calculate the overall chemo-completion rate among all patients

Secondary Outcome Measures

Name	Time	Method
Incidence of febrile neutropenia	60 days after the first chemotherapy
Incidence of Grade 3/4 ACN reduction	60 days after the first chemotherapy	evaluate the incidence of Grade 3/4 absolute neutrophil count
Duration of Grade 3/4 ACN reduction	60 days after the first chemotherapy	observe the duration of Grade 3/4 absolute neutrophil count

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China