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

NCT ID: NCT04477616

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-13
• Study Completion Date: 2022-11-06

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Day 7 regimen

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Day 3 regimen

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jue Wang

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaoming Zha, MD

Role: STUDY_DIRECTOR

The First Affiliated Hospital with Nanjing Medical University

Locations

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 39533204 (View on PubMed)

Other Identifiers

NBC Che001

Identifier Type: -

Identifier Source: org_study_id