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Completed

NCT Number: NCT01735175

Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta®

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.

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Key information

Conditions

Neutropenic Complications Agranulocytosis Breast Diseases Breast Neoplasms Chemotherapeutic Toxicity Chemotherapy-induced Neutropenia Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neoplasms Neoplasms by Site Neutropenia Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Sandoz Investigational Site, Ijuí, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LA-EP2006

Drug

Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.

Other names: pegfilgrastim

Neulasta®

Drug

Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.

Other names: pegfilgrastim

Primary outcomes

  1. Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy

    Time frame: 21 days (Cycle 1 of chemotherapy treatment)

    Mean duration of severe neutropenia, defined as number of consecutive days with ANC <0.5 × 10^9 cells/L (grade 4 neutropenia).

Secondary outcomes

  1. Incidence of Febrile Neutropenia (FN)

    Time frame: across all cycles (18 weeks)

    FN was defined as an oral temperature ≥ 38.3°C while having an absolute neutrophil count (ANC) < 0.5 × 10^9 cells/L. Serious treatment-emergent adverse events (TEAEs) were reconciled with the fever and ANC results recorded in the patient diary and CRF and therefore only the serious TEAEs of FN ("febrile neutropenia", "neutropenic sepsis") were taken into account.

  2. Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles

    Time frame: across al cycles (18 weeks)

    Fever was defined as an oral temperature ≥ 38.3°C. Fever episodes were characterized by maximum oral temperature and the number of patients who had fever at least once.

  3. Depth of ANC Nadir in Cycle 1

    Time frame: Cycle 1 (3 weeks)

    The depth of ANC nadir was defined as the patient's lowest ANC (10^9 cells/L) in Cycle 1. Only the evaluable patients with a depth of ANC in Cycle 1 are given.

  4. Number of Patients With ANC Nadir Per Day in Cycle 1

    Time frame: Cycle 1 (3 weeks)

    Numbers of patients with ANC nadir based per day during Cycle 1 are given.

  5. Time to ANC Recovery in Days in Cycle 1

    Time frame: across Cycle 1 (3 weeks)

    Time to absolute neutrophil count (ANC) recovery in Cycle 1 was defined as the time in days from ANC nadir until the patient's ANC had increased to ≥ 2 × 10^9 cells/L. Only the evaluable patients with a depth of ANC in Cycle 1 and a later increase of ANC ≥ 2 × 10^9 cells/L are given.

  6. Frequency of Infections by Cycle and Across All Cycles

    Time frame: across all cycles (18 weeks)

    The number of patients with infections was recorded for each cycle and across all cycles. Infections were identified by the AE documentation page selecting all events coded with System Organ Class "Infections and Infestations".

  7. Mortality Due to Infection

    Time frame: Study course (41 weeks)

    Number of patients with death due to infections

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Collaborators

  • Sandoz GmbH

Registry information

Official study 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

Acronym: PROTECT-1

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Nov 28, 2012
Registry last updated
Aug 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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