Status:
COMPLETED
Injection Regimen Trial of PEG-rhG-CSF During Breast Cancer Chemotherapy
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
July 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2022
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04477616
Start Date
July 13 2021
End Date
November 6 2022
Last Update
February 23 2023
Active Locations (1)
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1
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China