Clinical trial NCT04009941: Efficacy and Safety of 4.5mg PEG-rhG-CSF Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer
Official title: Study on the Efficacy and Safety of 4.5mg Pegylated Recombinant Human Granulocyte Colony Stimulating Factor Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Neutropenia
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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 abusers, alcoholics
* Pregnant or lactating women
* Severe mental or neurological disorders that affect informed consent and adverse reactions described or observed

Primary outcomes:
measure: RDI for each EC chemotherapy
timeFrame: 60 days after the first chemotherapy
measure: Chemotherapeutic dose adjustment due to neutropenia
timeFrame: 60 days after the first chemotherapy
measure: overall completion rate of chemotherapy
timeFrame: 60 days after the first chemotherapy
Secondary outcomes:
measure: Incidence of febrile neutropenia
timeFrame: 60 days after the first chemotherapy
measure: Incidence of Grade 3/4 ACN reduction
timeFrame: 60 days after the first chemotherapy
measure: Duration of Grade 3/4 ACN reduction
timeFrame: 60 days after the first chemotherapy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References: