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

• Sponsor: Peking University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04009941
• Collaborator: (none)
• Enrollment: 104
• Location: 1
• Arm: 1
• Actual Duration (Months): 6
• Patients Per Site Per Month: 17.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Neutropenia	Drug: PEG-rhG-CSF	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 104 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Aug 1, 2019
• Actual Primary Completion Date: Jan 18, 2020
• Actual Study Completion Date: Jan 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. RDI for each EC chemotherapy [60 days after the first chemotherapy]

   Ratio of actual dose intensity to standard dose intensity

2. Chemotherapeutic dose adjustment due to neutropenia [60 days after the first chemotherapy]

   percentage of dose decreasing due to neutropenia

3. overall completion rate of chemotherapy [60 days after the first chemotherapy]

   calculate the overall chemo-completion rate among all patients

Secondary Outcome Measures

1. Incidence of febrile neutropenia [60 days after the first chemotherapy]

2. Incidence of Grade 3/4 ACN reduction [60 days after the first chemotherapy]

   evaluate the incidence of Grade 3/4 absolute neutrophil count

3. Duration of Grade 3/4 ACN reduction [60 days after the first chemotherapy]

   observe the duration of Grade 3/4 absolute neutrophil count

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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>=3109/L, ANC>=1.5109/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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Cancer Hospital	Beijing	Beijing	China	100142

Sponsors and Collaborators

• Peking University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tao OUYANG, chief of breast surgery, Peking University
• ClinicalTrials.gov Identifier: NCT04009941
• Other Study ID Numbers: BC-P26
• First Posted: Jul 8, 2019
• Last Update Posted: Oct 28, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Breast Neoplasms; Neutropenia

Study Results

No Results Posted as of Oct 28, 2020