Breast Cancer Clinical Trial
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim
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.
Full Description
The Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2) was a confirmatory efficacy and safety study designed to compare the proposed biosimilar LA-EP2006 with the reference pegfilgrastim in woman with early stage breast cancer receiving (neo)-adjuvant myelosuppressive chemotherapy. Patient received TAC (intravenous docetaxel 75mg/m^2, doxorubicin 50 mg/m^2, and cyclophosphamide 500mg/m^2) on day1 of each cycle, for six or more cycles. A total of 308 patients were randomized to LA-EP2006 (n=155) or reference Neulasta® (n=153). Treatment was given subcutaneously on day 2 of each cycle. 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 cells/L). LA-EP2006 was equivalent to the reference product in DSN (difference: -0.16 days; 95% CI [-0.40, 0.08]). Further, LA-EP2006 and the reference pegfilgrastim showed no clinically meaningful differences regarding efficacy and safety.
Eligibility Criteria
Inclusion Criteria:
histologically proven breast cancer
eligible for six cycles of neoadjuvant or adjuvant chemotherapy
Exclusion Criteria:
concurrent or prior chemotherapy for breast cancer
concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunotherapy, monoclonal antibodies, and/or biological therapy
concurrent prophylactic antibiotics
previous therapy with any G-CSF (granulocyte-colony stimulating factor) product
Other protocol-defined inclusion/exclusion criteria may apply.
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There are 53 Locations for this study
Hot Springs Arkansas, 71913, United States
Jonesboro Arkansas, 72401, United States
Corona California, 92879, United States
Wichita Kansas, 67214, United States
Mount Sterling Kentucky, 40353, United States
Detroit Michigan, 48202, United States
Bismarck North Dakota, 58501, United States
Eugene Oregon, 97401, United States
Germantown Tennessee, 38138, United States
Newport News Virginia, 23601, United States
Tucuman , 4000, Argentina
Temuco , 48104, Chile
Chennai , 60003, India
Delhi , 11009, India
Gujarat , 38000, India
Hyderabad , 50024, India
Karamsad , 38832, India
Lucknow , 22600, India
Maharashtra , 42200, India
Mangalore , 57500, India
Mumbai , 40001, India
Pradesh , 52000, India
Surat , 39501, India
Vadodara , 39176, India
Vellore , 63200, India
Visakhapatnam , 53001, India
Kelantan , 16150, Malaysia
Nilai , 71800, Malaysia
Penang , 11200, Malaysia
Penang , 11600, Malaysia
San Juan , 00910, Puerto Rico
San Juan , 00927, Puerto Rico
Arkhangelsk , 16304, Russian Federation
Bashkortostan , 45005, Russian Federation
Bryansk , 24103, Russian Federation
Kazan , 42002, Russian Federation
Krasnoyarsk , 66013, Russian Federation
Moscow , 11547, Russian Federation
Omsk , 64404, Russian Federation
Orel , 30202, Russian Federation
Orenburg , 46002, Russian Federation
Rostov-na-Donu , 34403, Russian Federation
St Petersburg , 19775, Russian Federation
St. Petersburg , 19401, Russian Federation
St. Petersburg , 19404, Russian Federation
St. Petersburg , 19527, Russian Federation
St. Petersburg , 19702, Russian Federation
Tomsk , 63400, Russian Federation
Vladimir , 60002, Russian Federation
Barcelona , 08035, Spain
Madrid , 28040, Spain
Santiago de Compostela , 15706, Spain
Valencia , 46014, Spain
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