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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Day 7 regimen; Drug: Day 3 regimen

• Registration Number: NCT04477616
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-16
• Study First Posted: 2020-07-20
• Study Start: 2021-07-13
• Primary Completion: 2022-10-06
• Study Completion: 2022-11-06
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Experimental/PEG-rhG-CSF	Day 7 regimen	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.
Comparator: Comparator/PEG-rhG-CSF	Day 3 regimen	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.

Primary Outcome Measures

Name	Time	Method
the rates of grade III/IV neutropenia during the first and second chemotherapy cycle	up to 9 weeks	grade III or IV neutropenia (ANC \< 1x 10\^9/L or 0.5 x 10\^9/L)
the rates of FN during the first and second chemotherapy cycle	up to 9 weeks	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 .）

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with down-regulated dosage of PEG-rhG-CSF from 6mg to 3mg	up to 9 weeks	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
Adverse reactions after injection of PEG-rhG-CSF during first and second chemotherapy cycle	up to 9 weeks	Adverse reactions

Trial Locations

Locations (1)

the First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China