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

Primary Purpose

Breast Cancer

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Day 7 regimen

Day 3 regimen

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring PEG-rhG-CSF, Bone marrow suppression, Febrile neutropenia, Breast cancer, Chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Eligibility Criteria:

Female breast cancer aged 18-70 years old, the expected survival period is greater than 12 months.
No previous radiotherapy and chemotherapy.
No history of serious systemic disease.
KPS≥70.
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.
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.
Serum muscle plasma <1.5 times the upper limit of normal value.
No abnormal blood coagulation.
Women of childbearing age had a negative serum or urine pregnancy test before the start of treatment and agreed to contraception during treatment.
Cardiac function: two-dimensional echocardiography examination LVEF (left ventricular ejection fraction) ≥ 55%.
Sign informed consent.

Exclusion Criteria:

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).

Sites / Locations

the First Affiliated Hospital of Nanjing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental: Experimental/PEG-rhG-CSF

Comparator: Comparator/PEG-rhG-CSF

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

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 .）

Secondary Outcome Measures

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

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

Adverse reactions

Full Information

NCT ID

NCT04477616

First Posted

July 16, 2020

Last Updated

February 21, 2023

Sponsor

The First Affiliated Hospital with Nanjing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04477616

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

July 13, 2021 (Actual)

Primary Completion Date

October 6, 2022 (Actual)

Study Completion Date

November 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental: Experimental/PEG-rhG-CSF

Arm Type

Experimental

Arm Description

Arm Title

Comparator: Comparator/PEG-rhG-CSF

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Day 7 regimen

Intervention Description

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

Intervention Name(s)

Day 3 regimen

Intervention Description

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.

Primary Outcome Measure Information:

Title

the rates of grade III/IV neutropenia during the first and second chemotherapy cycle

Description

grade III or IV neutropenia (ANC < 1x 10^9/L or 0.5 x 10^9/L)

Time Frame

up to 9 weeks

Title

the rates of FN during the first and second chemotherapy cycle

Description

Time Frame

up to 9 weeks

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

up to 9 weeks

Title

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

Description

Adverse reactions

Time Frame

up to 9 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Eligibility Criteria: Female breast cancer aged 18-70 years old, the expected survival period is greater than 12 months. No previous radiotherapy and chemotherapy. No history of serious systemic disease. KPS≥70. 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. 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. Serum muscle plasma <1.5 times the upper limit of normal value. No abnormal blood coagulation. Women of childbearing age had a negative serum or urine pregnancy test before the start of treatment and agreed to contraception during treatment. Cardiac function: two-dimensional echocardiography examination LVEF (left ventricular ejection fraction) ≥ 55%. Sign informed consent. Exclusion Criteria: 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaoming Zha, MD

Organizational Affiliation

The First Affiliated Hospital with Nanjing Medical University

Official's Role

Study Director

Facility Information:

Facility Name

the First Affiliated Hospital of Nanjing Medical University

City

Nanjing

State/Province

Jiangsu

Country

China

12. IPD Sharing Statement

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

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