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Brief Title: Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta®
Official Title: A Randomized, Double-blind, Parallel-group, Multi-center Phase 3 Comparative Study Investigating Efficacy and Safety of LA-EP2006 and Neulasta® in Breast Cancer Patients Treated With Myelosuppressive Chemotherapy
Study ID: NCT01735175
Brief Summary: The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
Detailed Description: This randomized, double-blind trial compared the proposed biosimilar LA-EP2006 with the reference Neulasta® in women (≥18 years) receiving chemotherapy for breast cancer. Therefore patients were randomized to receive LA-EP2006 (n = 159) or the reference product (n = 157) for ≤6 cycles of (neo)-adjuvant TAC (docetaxel 75mg/m\^2, doxorubicin 50 mg/m\^2, and cyclophosphamide 500mg/m\^2) chemotherapy. The primary end point was the duration of severe neutropenia (DSN) during Cycle 1 (defined as number of consecutive days with absolute neutrophil count \<0.5 × 10\^9/l). The equivalence was confirmed if 95% CIs were within a ±1 day margin. LA-EP2006 was equivalent to the reference product in DSN (difference: 0.07 days; 95% CI \[-0.12, 0.26\]). Further, LA-EP2006 and the reference Neulasta® showed no clinically meaningful differences regarding efficacy and safety.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Sandoz Investigational Site, Ijui, , Brazil
Sandoz Investigational Site, Lajeado, , Brazil
Sandoz Investigational Site, Santo Andre, , Brazil
Sandoz Investigational Site, Andhra Pradesh, , India
Sandoz Investigational Site, Delhi, , India
Sandoz Investigational Site, Madurai, , India
Sandoz Investigational Site, Maharashtra, , India
Sandoz Investigational Site, Maharashtra, , India
Sandoz Investigational Site, Maharashtra, , India
Sandoz Investigational Site, Mumbai, , India
Sandoz Investigational Site, Rajasthan, , India
Sandoz Investigational Site, Aguascalientes, , Mexico
Sandoz Investigational Site, Juchitan, , Mexico
Sandoz Investigational Site, Bucharest, , Romania
Sandoz Investigational Site, Bucharest, , Romania
Sandoz Investigational Site, Iasi, , Romania
Sandoz Investigational Site, Suceava, , Romania
Sandoz Investigational Site, Barnaul, , Russian Federation
Sandoz Investigational Site, Bashkortostan, , Russian Federation
Sandoz Investigational Site, Berdsk, , Russian Federation
Sandoz Investigational Site, Ivanovo, , Russian Federation
Sandoz Investigational Site, Kabardino, , Russian Federation
Sandoz Investigational Site, Kazan, , Russian Federation
Sandoz Investigational Site, Krasnodar, , Russian Federation
Sandoz Investigational Site, Kursk, , Russian Federation
Sandoz Investigational Site, Leningrad, , Russian Federation
Sandoz Investigational Site, Moscow, , Russian Federation
Sandoz Investigational Site, Novgorod, , Russian Federation
Sandoz Investigational Site, Oktyabrskaya, , Russian Federation
Sandoz Investigational Site, Ryazan, , Russian Federation
Sandoz Investigational Site, St. Petersburg, , Russian Federation
Sandoz Investigational Site, Tula, , Russian Federation
Sandoz Investigational Site, Cherkasy, , Ukraine
Sandoz Investigational Site, Chernivtsi, , Ukraine
Sandoz Investigational Site, Dnipropetrovsk, , Ukraine
Sandoz Investigational Site, Kharkiv, , Ukraine
Sandoz Investigational Site, Kriviy Rig, , Ukraine
Sandoz Investigational Site, Lugansk, , Ukraine
Sandoz Investigational Site, Mariupol, , Ukraine
Sandoz Investigational Site, Vinnytsya, , Ukraine
Sandoz Investigational Site, Zaporizhzhia, , Ukraine
Name: Sandoz Biopharmaceutical Clinical Development
Affiliation: Sandoz
Role: STUDY_CHAIR