Randomized, OpEn-Label, Active-ContrOl Trial of SPI-2012 (Eflapegrastim) Versus Pegfilgrastim in the Management of Chemotherapy-Induced Neutropenia in Early-Stage BReast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) (RECOVER)
Randomized, OpEn-Label, Active-ContrOl Trial of SPI-2012 (Eflapegrastim) Versus Pegfilgrastim in the Management of Chemotherapy-Induced Neutropenia in Early-Stage BReast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) (RECOVER)
The purpose of this study is to compare the efficacy of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) as measured by the duration of severe neutropenia (DSN).
This is a Phase 3, randomized, open-label, active-controlled, multicenter study to compare the efficacy and safety of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer treated with TC chemotherapy as measured by the duration of severe neutropenia (DSN).
Each cycle was 21 days. Four cycles were evaluated for this study. On Day 1 of each cycle, participants received TC chemotherapy. On Day 2 of each cycle, participants received study drug (SPI-2012 or pegfilgrastim).
After cycle 1, as applicable, participants who received at least one dose of study drug will be followed for safety for 12 months after the last dose of study treatment.
Key Inclusion Criteria:
Key Exclusion Criteria:
Fresno, California 93720, United States
Whittier, California 90603, United States
Grand Island, Nebraska 68803, United States
Youngstown, Ohio 44501, United States
Miskolc, 3526, Hungary
Nyíregyháza, 4400, Hungary
Bialystok, 15-027, Poland
Grudziądz, 86-300, Poland
Lodz, 93-338, Poland
Poznan, 60-569, Poland
Racibórz, 47-400, Poland
Rzeszów, 35-021, Poland
Szczecin, 71-730, Poland
Irwon-ro, Gangnam-gu Seoul 06351, South Korea
Ilsan-ro, Gangwon-do 26426, South Korea
IIsan-ro, Gyeonggi-do 10408, South Korea
Yatap-ro, Gyeonggi-do 13496, South Korea
Daehwa-ro, Jongno-gu Seoul 03080, South Korea
Inhang-ro, Jung-guIncheon 22332, South Korea
Inchon-ro, Seongbuk-guSeoul 02841, South Korea
Yonsei-ro, Seoul 03722, South Korea