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

Study on the Efficacy and Safety of 4.5mg Pegylated Recombinant Human Granulocyte Colony Stimulating Factor Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Neutropenia
• Intervention / Treatment: Drug: PEG-rhG-CSF

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEG-rhG-CSF; Patients with breast cancer who were treated with intensive chemotherapy received PEG-rhG-CSF.	Drug: PEG-rhG-CSF; 4.5mg per cycle, 24 hours after chemotherapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): January 18, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: June 30, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 8, 2019

Study Record Updates

• Last Update Posted (Actual): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 26, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Hematologic Diseases; Breast Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Breast Neoplasms; Neutropenia
• Other Study ID Numbers: BC-P26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No