A Phase III, Multi-Center, Randomized, Open-Label, Active-Controlled Trial to Compare the Efficacy and Safety of Recombinant Human Granulocyte Colony Stimulating Factor-Fc Fusion Protein (F-627) and Recombinant Human Granulocyte Colony Stimulating Factor (GRAN®) in the Prophylactic Treatment for Chemotherapy-Induced Neutropenia
Study Stage: Phase III Study Population: Female patients with breast cancer will be enrolled to receive at least 4 cycles of Epirubicin + Cyclophosphamide (EC) chemotherapy, that is: epirubicin 100 mg/m\^2 and cyclophosphamide 600 mg/m\^2. Study Design: A multi-center, randomized, open-label, active-controlled phase III clinical trial
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
242
Day 3 of each cycle, i.e., 48 ± 4 h after starting chemotherapy
Since day 3 of each cycle, i.e., 48 ± 4 h after starting chemotherapy, continuous treatment for ≤ 2 weeks or until ANC recovers to 5.0 × 10\^9/L from nadir (investigators may refer to ANC test results from the Department of Laboratory Medicine of each study sites to decide when to discontinue GRAN®)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Duration of Grade 3 or 4 Neutropenia (ANC <1.0×10^9/L) in Cycle 1
Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Number of Participants With Grade 3 or 4 Neutropenia in Cycle 1
Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L
Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Number of Participants With Grade 3 or 4 Neutropenia in Cycle 2
Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L
Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Number of Participants With Grade 3 or 4 Neutropenia in Cycle 3
Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L
Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Number of Participants With Grade 3 or 4 Neutropenia in Cycle 4
Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L
Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Duration of Grade 3 or 4 Neutropenia in Cycle 2
Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration of Grade 3 or 4 Neutropenia in Cycle 3
Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration of Grade 3 or 4 Neutropenia in Cycle 4
Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Number of Participants With Grade 4 Neutropenia in Cycle 1
Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L.
Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Number of Participants With Grade 4 Neutropenia in Cycle 2
Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L.
Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Number of Participants With Grade 4 Neutropenia in Cycle 3
Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L.
Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Number of Participants With Grade 4 Neutropenia in Cycle 4
Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L.
Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration of Grade 4 Neutropenia in Cycle 1
Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration of Grade 4 Neutropenia in Cycle 2
Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration of Grade 4 Neutropenia in Cycle 3
Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration of Grade 4 Neutropenia in Cycle 4
Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Overall Duration of Grade 3 or 4 Neutropenia in 4 Cycles
Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Overall 4, 21-day chemotherapy cycles(average 12 weeks)
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 1
Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L
Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 2
Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L
Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 3
Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L
Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 4
Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L
Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 1
Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 2
Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 3
Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 4
Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
The Absolute Neutrophil Counts (ANC) Nadir From Day 3 to Day 13 of Cycle 1
The minimum value of ANC measured from day 3 to day 13 of cycle 1
Time frame: From day 3 to day 13 of cycle 1 (11 days)
Number of Participants With Febrile Neutropenia (FN) in Cycle 1
FN is defined as ANC \< 1.0 × 10\^9/L with fever (a single measurement of body temperature \>38.3 °C or body temperature ≥ 38.0 °C for more than 1 hr).
Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 1
If the ANC nadir during the first 13 days of the cycle is \< 2.0 × 10\^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10\^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10\^9/L, then the recovery time = 0 days.
Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 2
If the ANC nadir during the first 13 days of the cycle is \< 2.0 × 10\^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10\^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10\^9/L, then the recovery time = 0 days.
Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 3
If the ANC nadir during the first 13 days of the cycle is \< 2.0 × 10\^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10\^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10\^9/L, then the recovery time = 0 days.
Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 4
If the ANC nadir during the first 13 days of the cycle is \< 2.0 × 10\^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10\^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10\^9/L, then the recovery time = 0 days.
Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)