Nanogen Pegcyte Clinical Study for the Prevention of CIN in Breast-cancer Patients.
Status:
Completed
Trial end date:
2017-11-06
Target enrollment:
Participant gender:
Summary
Accelerated AC regimen-Doxorubicin 60 mg/m2,Cyclophosphamide 600 mg/m2 on day 1 & day 14 of
each cycle along with G-CSF support for up to 4 cycles, followed by Paclitaxel 175 mg/m2 in
the next 4 cycles is the standard clinical practice in Vietnam for breast cancer, this
regimen is to facilitate the dose-dense schedule, patients receive every-2-week therapy along
with G-CSF support. the accelerated dose-dense schedule improve disease-free and overall
survival among women with breast cancer .Primary objective of this study is to compare the
efficacy and safety of Nanogen's Pegcyte and Roche's Neulastim for prevention of chemotherapy
(Accelerated AC regimen)-induced neutropenia on breast cancer patients. Breast cancer
patients scheduled to receive myelosuppressive chemotherapy (AC regimen) will be recruited in
this trial. All eligible patients receive single subcutaneous injection of study drugs 24
hours after chemotherapy administration in each cycle for 3 consecutive cycles. Efficacy and
safety assessments will be assessed based on the incidence of severe neutropenia in
combination of temperature > 38.3℃ or sepsis or life threatening infection and incidence of
serious adverse events.
Phase:
Phase 3
Details
Lead Sponsor:
Nanogen Pharmaceutical Biotechnology Joint Stock Company