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Completed

NCT Number: NCT01516736

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

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

Chemotherapy-induced Neutropenia Agranulocytosis Breast Cancer Breast Diseases Breast Neoplasms 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, San Miguel de Tucumán, Argentina

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About this study

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.

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 LA-EP2006 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 Neulasta® is injected s.c. post chemotherapy application.

Other names: pegfilgrastim, Neulasta

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/l (grade 4 neutropenia).

Secondary outcomes

  1. Incidence of Febrile Neutropenia (FN)

    Time frame: across all cycles (18 weeks)

    FN was defined as 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 body temperature of ≥ 38.3°C. Fever episodes were described 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.

  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 was defined as the time in days from ANC nadir until the patient's ANC had increased to ≥ 2 × 10^9 cells/L after the nadir in Cycle 1.

  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 (19 weeks)

    Number of patients with death due to infections

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Collaborators

  • Sandoz GmbH

Registry information

Official study title

Pivotal Study in Breast Cancer Patients Investigating Efficacy and Safety of LA-EP2006 and Neulasta®

Acronym: PROTECT2

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 25, 2012
Registry last updated
Aug 30, 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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