Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim (PROTECT2)

Sandoz

Status and phase: Completed; Phase 3

Conditions: Breast Cancer; Chemotherapy-induced Neutropenia

Treatments: Drug: Neulasta®; Drug: LA-EP2006

Study type: Interventional

Funder types: Industry

Identifiers

NCT01516736

LA-EP06-302

Details and patient eligibility

About

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.

Enrollment: 308 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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308 participants in 2 patient groups

LA-EP2006

Experimental group

Description:

During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.

Treatment:

Drug: LA-EP2006

Neulasta®

Active Comparator group

Description:

During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.

Treatment:

Drug: Neulasta®