Injection Regimen Trial of PEG-rhG-CSF During Breast Cancer Chemotherapy

Injection Regimen Trial of Pegylated Recombinant Human Granulocyte Colony Stimulating Factor (PEG-rhG-CSF) in Preventing Bone Marrow Suppression and/or Febrile Neutropenia (FN) During Breast Cancer Chemotherapy

The purpose of this study is to try to find a better injection regimen (including time and dose) of PEG-rhG-CSF, which is supposed to better prevent bone marrow suppression and/or FN in breast cancer patients who receive chemotherapy.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Day 7 regimen; Drug: Day 3 regimen

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rui Chen, MD; Phone Number: 00862568308172; Email: 15951756315@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Eligibility Criteria:

1. Female breast cancer aged 18-70 years old, the expected survival period is greater than 12 months.
2. No previous radiotherapy and chemotherapy.
3. No history of serious systemic disease.
4. KPS≥70.
5. White blood cell count> 3.5 × 10 ^ 9 / L, neutrophil count> 1.8 × 10 ^ 9 / L, platelet count> 100 × 10 ^ 9 / L, hemoglobin> 9 g / dl.
6. ALT (alanine transaminase) and AST (aspartate transaminase) <1.5 times the upper limit of normal value, alkaline phosphatase <2.5 times the upper limit of normal value, and total bilirubin <1.5 times the upper limit of normal value.
7. Serum muscle plasma <1.5 times the upper limit of normal value.
8. No abnormal blood coagulation.
9. Women of childbearing age had a negative serum or urine pregnancy test before the start of treatment and agreed to contraception during treatment.
10. Cardiac function: two-dimensional echocardiography examination LVEF (left ventricular ejection fraction) ≥ 55%.
11. Sign informed consent.

Exclusion Criteria:

1. Received systemic or local treatment for tumors, including chemotherapy, radiotherapy, and endocrine therapy.
2. A history of malignant tumors within 5 years (except curable skin basal cell carcinoma and cervical carcinoma in situ).
3. The patient has been enrolled in other clinical trials or used other study drugs 30 days before enrollment in this study.
4. Accompanied by uncontrolled lung disease, severe infection, active gastrointestinal ulcer need treatment, coagulopathy, severe uncontrolled diabetes, connective tissue disease or bone marrow function suppression, and other diseases, can not tolerate chemotherapy-related treatments.
5. Two-dimensional echocardiography detection LVEF <55%.
6. Severe cardiovascular and cerebrovascular diseases within the first 6 months of randomization (eg unstable angina, chronic heart failure, uncontrollable hypertension> 150/90 mmHg, myocardial infarction, or cerebrovascular accident).
7. NCI peripheral neurotoxicity grade ≥2.
8. Those taking glucocorticoids.
9. Known hypersensitivity to anthracyclines, cyclophosphamide, taxanes, trastuzumab, or pertuzumab.
10. Refuse contraception during treatment and within 8 weeks after completion of treatment for women of childbearing age.
11. Pregnant and lactating women.
12. After joining the test, a pregnancy test (+) before using the drug.
13. There are mental illness, cognitive impairment, unable to understand the test plan and side effects, unable to complete the test plan, and follow-up workers (systematic evaluation is required before the trial is enrolled).
14. No personal freedom and independent civil capacity.
15. The investigator determined that the patient could not obtain long-term follow-up data (due to unavailability or serious concomitant diseases).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Experimental/PEG-rhG-CSF; patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 7 (chemotherapy day was recorded as day 1). If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle.	Drug: Day 7 regimen; patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 7 after chemotherapy. If FN occurs in the experimental group and the control group, reduce the dose of chemotherapy in the next course of treatment, timely change the chemotherapy regimen, and closely monitor to ensure patient safety. Record the results of routine blood follow-up and temperature curves of patients at different time periods. If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle.
Active Comparator: Comparator: Comparator/PEG-rhG-CSF; patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 3 (chemotherapy day was recorded as day 1). If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle.	Drug: Day 3 regimen; patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 3 after chemotherapy. If FN occurs in the experimental group and the control group, reduce the dose of chemotherapy in the next course of treatment, timely change the chemotherapy regimen, and closely monitor to ensure patient safety. Record the results of routine blood follow-up and temperature curves of patients at different time periods. If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rates of grade III/IV neutropenia during the first and second chemotherapy cycle	grade III or IV neutropenia (ANC < 1x 10^9/L or 0.5 x 10^9/L)	up to 9 weeks
the rates of FN during the first and second chemotherapy cycle	the occurrent rate of FN（FN：Body temperature ≥38.3°C or ≥38.0°C continued for 1 h, with neutrophil count <500/mcl or neutrophil count <1000/mcl, but expected to drop to <500/ mcl after 48 hours .）	up to 9 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with down-regulated dosage of PEG-rhG-CSF from 6mg to 3mg	If WBC >= 10 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle	up to 9 weeks
Adverse reactions after injection of PEG-rhG-CSF during first and second chemotherapy cycle	Adverse reactions	up to 9 weeks

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Investigators: Study Director: Xiaoming Zha, MD, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2021
• Primary Completion (Actual): October 6, 2022
• Study Completion (Actual): November 6, 2022

Study Registration Dates

• First Submitted: July 16, 2020
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Breast cancer; Chemotherapy; Febrile neutropenia; PEG-rhG-CSF; Bone marrow suppression
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Hematologic Diseases; Breast Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Neutropenia; Breast Neoplasms; Febrile Neutropenia
• Other Study ID Numbers: NBC Che001

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