Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta® (PROTECT-1)

Sandoz

Status and phase: Completed; Phase 3

Conditions: Chemotherapy-induced Neutropenia; Neutropenic Complications; Chemotherapeutic Toxicity; Breast Neoplasms

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01735175

2011-004532-58 (EudraCT Number)

LA-EP06-301

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

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.

Enrollment: 316 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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316 participants in 2 patient groups

Neulasta®

Active Comparator group

Description:

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

Treatment:

Drug: Neulasta®

LA-EP2006

Experimental group

Description:

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

Treatment:

Drug: LA-EP2006