Efficacy and Safety of 4.5mg PEG-rhG-CSF Per Cycle in Preventing Neutropenia After Intensive Chem… (NCT04009941) | Clinical Trial Compass
CompletedPhase 4
Efficacy and Safety of 4.5mg PEG-rhG-CSF Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer
China104 participantsStarted 2019-08-01
Plain-language summary
This is a prospective, single-center, single-arm clinical study, to evaluate the clinical efficacy, safety and tolerance of patients with early breast cancer receiving ddEC adjuvant chemotherapy, accepting PEG-rhG-CSF as primary prevention of neutropenia.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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Inclusion Criteria:
* Breast cancer patients in need for adjuvant chemotherapy confirmed by histopathology, whom should accept ddEC regimen.
* ECOG\<=1
* Expected survival is greater than 6 months
* Qualified for chemotherapy,WBC\>=3\*109/L, ANC\>=1.5\*109/L, Hb\>=80g/L, PLT\>=80\*109/L. With no bleeding tendency or systemic hematology disorder symptoms.
* No obvious EKG abnormality, no obvious cardiac dysfunction, and normal left ventricular ejection fraction.
* Liver function, ALT and AST should less than 2.5 times of the upper limit.
* Renal function, Cr and BUN should less than 1.5 times of the upper limit.
* Subjects voluntarily participate in this study and sign informed consent.
Exclusion Criteria:
* Total amount of doxorubicin used in previous chemotherapy\>240mg/m2, or epirubicin\>360mg/m2
* Has received hematopoietic stem cell transplantation or bone marrow transplantation
* Other drugs are currently in clinical trials
* There are currently hard-to-control infections, body temperature is higher than 38 degrees.
* Received PEG-rhG-CSF treatment before enrollment
* Received chemotherapy in 4 weeks before enrollment
* Patients with any visceral metastasis
* Patients with severe heart, kidney, liver or any other important organs chronic diseases
* Patients with severe uncontrolled diabetes
* Patients with allergic diseases, or allergies to this product or other biological products derived from genetically engineered e. coli
* Suspected or real drug users, substance a…
What they're measuring
1
RDI for each EC chemotherapy
Timeframe: 60 days after the first chemotherapy
2
Chemotherapeutic dose adjustment due to neutropenia