This was a randomized, open-label, active-controlled, dose-finding, phase II study to evaluate the efficacy and safety of 2 doses of F-627 compared to Filgrastim in women with breast cancer receiving myelotoxic chemotherapy. Subjects would be randomized to one of three arms, which were 10 mg/dose of F-627, 20 mg/dose of F-627 or Filgrastim, in an equal ratio.
This phase II study was conducted at 16 clinical centers in China and planned to enroll 150 women with breast cancer who will receive chemotherapy that includes up to 4 cycles of epirubicin and cyclophosphamide, 100 mg/m2 and 600 mg/m2, respectively. Subjects would be randomized to one of three arms, which were 10 mg/dose of F-627, 20 mg/dose of F-627 or Filgrastim, in an equal ratio on Day 1 of the study. Patients will remain on their randomized study drug dose and regimen for each of the following 3 chemotherapy cycles. The chemotherapy to be administered for chemotherapy cycles 2-4 should be the same therapy administered to the subject on Day1. Chemotherapy will be administrated through intravenous IV) injection on Day 1 of each 21-day cycle and be repeated every 3 weeks for up to four cycles unless a dose delay is necessary. Approximately 48 hours after chemotherapy completion in cycle (day 3 of the cycle), patients will either receive a subcutaneous (SC) injection of F-627 (either 10 mg/dose or 20 mg/dose) or 5 μg/kg/dose filgrastim used up to two weeks or stopped while ANC more than 5 × 109/L. To track ANC concentration post chemotherapy, subjects returned to their study site for blood draws either daily (Cycle 1) or 3 times per week (every other day; Cycles 2-4) until ANC levels reached ≥2.0 × 109/L, post-nadir, and then every 3 days until the next chemotherapy cycle. All subjects returned for an End of Study visit approximately 3 weeks after their final study drug administration (Study Day 84) and had a follow-up phone call 30 days after the last study drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
138
F-627 at doses of 10 mg/dose or 20 mg/dose, s.c. on Day 3 of each cycle for up to 4 cycles.
Filgrastim at dose of 5 mcg/kg/day for up to 2 weeks, s.c. start from Day 3 of each cycle for up to 4 cycles.
Fudan University Shanghai Cancer Center
Shanghai, China
The duration of moderate or severe (grade 3 and 4, respectively) neutropenia
The duration of moderate or severe (grade 3 and 4, respectively) neutropenia post chemotherapy as measure of efficacy of F-627 compared to Filgrastim in female patients wiht breast cance receiving adjuvant chemotherapy.
Time frame: In first of 4 cycles (21 days for each cycle) 84 days
The incidence rates of Grade 3 and Grade 4 neutropenia
The incidence rates of Grade 3 and Grade 4 neutropenia (ANC \< 1.0 × 109/L and \< 0.5 × 109/L, respectively) for all chemotherapy cycles.
Time frame: up to 4 cycles (84 days)
The duration in days of Grade 3 and Grade 4 neutropenia for cycle 2 to 4.
The duration in days of Grade 3 and Grade 4 neutropenia (ANC \<1.0 × 109/L and ANC \<0.5 × 109/L, respectively) for cycle 2 to 4.
Time frame: cycle 2-4 (63 days)
The incidence rates of febrile neutropenia
The incidence rates of febrile neutropenia (FN; defined as a decrease in neutrophils associated with fever) for each chemotherapy cycle.
Time frame: Up to 4 cycles (84 days)
The depth of the ANC nadir
The depth of the ANC nadir for chemotherapy Cycles 1 to 4.
Time frame: Up to 4 cycles (84 days)
Number of participants with adverse events, changes from baseline of laboratory
Number of participants with adverse events, changes from baseline of laboratory values as measure of safety of F-627 compared to Filgrastim in female patients with breast cancer receiving chemotherapy.
Time frame: Up to 4 cycles (84 days)
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