Study to Compare the Efficacy and Safety of F-627 and GRAN® (NCT04174599) | Clinical Trial Compass
CompletedPhase 3
Study to Compare the Efficacy and Safety of F-627 and GRAN®
China242 participantsStarted 2018-04-12
Plain-language summary
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
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. Willing to sign the informed consent form and able to comply with protocol requirements;
✓. 18-75 years old;
✓. Female postoperative patients with breast cancer who require adjuvant chemotherapy, and are planned to receive at least 4 cycles of EC chemotherapy, namely epirubicin 100 mg/m\^2 + cyclophosphamide 600 mg/m\^2;
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
✓. Hepatic and renal functions: Total bilirubin ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, serum creatinine ≤ 1.5 × ULN;
✓. Left ventricular ejection fraction \> 50%;
✓. Women without child-bearing potential, i.e., women who have had menopause for at least 1 year or who have undergone sterilization (bilateral tubal ligation, double oophorectomy or hysterectomy); patients with child-bearing potential should agree to take appropriate contraceptive measures, including condoms, spermicidal condoms, foams, gels, contraceptive barrier, intrauterine devices (IUD), and contraceptives (oral or injection), starting from 1 month before the start of the study until 30 days after the end of the study.
Exclusion criteria
✕. Radiation therapy within 4 weeks prior to enrollment;
✕
What they're measuring
1
Duration of Grade 3 or 4 Neutropenia (ANC <1.0×10^9/L) in Cycle 1
Timeframe: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)