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

NCT04477616 | Completed Phase 2

• 1 other identifier: NBC Che001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

PEG-rhG-CSF; Bone marrow suppression; Febrile neutropenia; Breast cancer; Chemotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Proportion of patients with down-regulated dosage of PEG-rhG-CSF from 6mg to 3mg

  up to 9 weeks

• Adverse reactions after injection of PEG-rhG-CSF during first and second chemotherapy cycle

  up to 9 weeks

Study Arms (2)

Experimental: Experimental/PEG-rhG-CSF

EXPERIMENTAL

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

Comparator: Comparator/PEG-rhG-CSF

ACTIVE COMPARATOR

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

Interventions

Day 7 regimen DRUG

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.

Experimental: Experimental/PEG-rhG-CSF

Day 3 regimen DRUG

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.

Comparator: Comparator/PEG-rhG-CSF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Received systemic or local treatment for tumors, including chemotherapy, radiotherapy, and endocrine therapy.
• A history of malignant tumors within 5 years (except curable skin basal cell carcinoma and cervical carcinoma in situ).
• The patient has been enrolled in other clinical trials or used other study drugs 30 days before enrollment in this study.
• 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.
• Two-dimensional echocardiography detection LVEF \<55%.
• 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).
• NCI peripheral neurotoxicity grade ≥2.
• Those taking glucocorticoids.
• Known hypersensitivity to anthracyclines, cyclophosphamide, taxanes, trastuzumab, or pertuzumab.
• Refuse contraception during treatment and within 8 weeks after completion of treatment for women of childbearing age.
• Pregnant and lactating women.
• After joining the test, a pregnancy test (+) before using the drug.
• 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).
• No personal freedom and independent civil capacity.
• The investigator determined that the patient could not obtain long-term follow-up data (due to unavailability or serious concomitant diseases).

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

Related Publications (1)

• Xu Y, Huang L, Wang J, He J, Wang Y, Zhang W, Chen R, Huang X, Liu J, Wan X, Shi W, Xu L, Zha X. Exploring optimal administration timing of pegylated recombinant human granulocyte colony-stimulating factor for chemotherapy-induced neutropenia in early breast cancer treated with pharmorubicin and endoxan: a prospective randomized controlled clinical trial. BMC Cancer. 2024 Nov 12;24(1):1387. doi: 10.1186/s12885-024-13156-y.

  PMID: 39533204 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Febrile Neutropenia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Xiaoming Zha, MD

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 20, 2020
• Study Start: July 13, 2021
• Primary Completion: October 6, 2022
• Study Completion: November 6, 2022
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

CN (1)