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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04009941
• Other study ID #: BC-P26
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: October 2020
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: January 31, 2020
• Est. primary completion date: January 18, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neutropenia

Intervention

Drug:
• PEG-rhG-CSF
4.5mg per cycle, 24 hours after chemotherapy

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RDI for each EC chemotherapy	Ratio of actual dose intensity to standard dose intensity	60 days after the first chemotherapy
Primary	Chemotherapeutic dose adjustment due to neutropenia	percentage of dose decreasing due to neutropenia	60 days after the first chemotherapy
Primary	overall completion rate of chemotherapy	calculate the overall chemo-completion rate among all patients	60 days after the first chemotherapy
Secondary	Incidence of febrile neutropenia		60 days after the first chemotherapy
Secondary	Incidence of Grade 3/4 ACN reduction	evaluate the incidence of Grade 3/4 absolute neutrophil count	60 days after the first chemotherapy
Secondary	Duration of Grade 3/4 ACN reduction	observe the duration of Grade 3/4 absolute neutrophil count	60 days after the first chemotherapy