In the study, subjects will scheduled to undergo four 21-days cycles of chemotherapy treatment. Three group were treated with MW05 300 μg/kg or MW05 500 μg/kg or PEG-rhG-CSF 100 μg/kg on the 3th day of each cycle randomized 1:1:1 . The dose of the experimental drug MW05 in phase III were determined by independent data monitoring committee (IDMC) according to the efficacy and safety of phase II. Subjects were randomly divided into two groups 1:1 to received either MW05 or PEG-rhG-CSF(100 μg/kg) on the 3th day of each chemotherapy cycle.
Study Stage: Phase II/III Study Population Female patients with breast cancer will be enrolled to receive at least 4 cycles of TC chemotherapy, that is: Docetaxel 75 mg/m2 and Cyclophosphamide 600 mg/m2. Study Design: A multi-center, randomized, open-label, active-controlled phase II/III clinical trial
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
586
Recombinant (yeast secreted) human serum albumin-human granulocyte colony stimulating factor (I) fusion protein injection
PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor
Fudan University Affiliated Cancer Hospital
Shanghai, China
The primary objective of this study will be to evaluate the efficacy of MW05 pre-filled syringe as compared to PEG-rhG-CSF standard dosing (6 mg) in the first chemotherapy cycle.
The primary endpoint will be the duration of grade 4 (severe) neutropenia - the number of days in which the patient has had an absolute neutrophil count (ANC \<0.5 x 109/L) observed in chemotherapy cycle 1.
Time frame: in cycle 1(each cycle is 21 days)
The duration of grade 4 neutropenia in cycle 2~4 assessed by ANC(ANC < 0.5 × 109/L)
The duration of grade 4 neutropenia (ANC\< 0.5 × 109/L)
Time frame: in cycles 2-4, in overall 3 cycles(each cycle is 21 days)
The incidence of grade 4 neutropenia in cycle 1~4 assessed by ANC(ANC < 0.5 × 109/L)
The incidence rate of grade 4 neutropenia (ANC\< 0.5 × 109/L)
Time frame: through study completion, in overall 4 cycles(each cycle is 21 days)
The incidence of grade 3 or 4 neutropenia in cycle 1~4 assessed by ANC(ANC < 1.0 × 109/L and ANC < 0.5 × 109/L, respectively)
The incidence rate of grade 3 or 4 neutropenia (ANC \< 1.0 × 109/L and ANC\< 0.5 × 109/L, respectively)
Time frame: through study completion, in overall 4 cycles(each cycle is 21 days)
The duration of grade 3 or 4 neutropenia In cycle 1~4 assessed by ANC(ANC < 1.0 × 109/L and ANC < 0.5 × 109/L, respectively)
The duration of grade 3 or 4 neutropenia (ANC \< 1.0 × 109/L and ANC\< 0.5 × 109/L, respectively)
Time frame: through study completion, in overall 4 cycles(each cycle is 21 days)
Incidence of febrile neutropenia (FN) (defined as ANC < 1.0×109/L; a single measurement of body temperature > 38.3°C or a temperature ≥ 38.0 °C sustained over 1 h)
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Rate of febrile neutropenia (FN) (defined as ANC \< 1.0×109/L; a single measurement of body temperature \> 38.3 °C or a temperature ≥ 38.0 °C sustained over 1 h)
Time frame: through study completion, in overall 4 cycles(each cycle is 21 days)
The proportion of subjects rescued by short-acting G-CSF in cycle 1~4.
The proportion of received short-acting G-CSF.
Time frame: through study completion, in overall 4 cycles(each cycle is 21 days)