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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01516736
First Posted: January 25, 2012
Last Update Posted: August 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sandoz GmbH
Information provided by (Responsible Party):
Sandoz
  Purpose
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.

Condition Intervention Phase
Chemotherapy-induced Neutropenia Breast Cancer Drug: LA-EP2006 Drug: Neulasta® Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Pivotal Study in Breast Cancer Patients Investigating Efficacy and Safety of LA-EP2006 and Neulasta®

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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".

  • Mortality Due to Infection [ Time Frame: Study course (19 weeks) ]
    Number of patients with death due to infections


Enrollment: 308
Study Start Date: March 2012
Study Completion Date: December 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LA-EP2006
During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
Drug: LA-EP2006
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 Name: pegfilgrastim
Active Comparator: Neulasta®
During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Drug: Neulasta®
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

Detailed 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516736


  Show 53 Study Locations
Sponsors and Collaborators
Sandoz
Sandoz GmbH
Investigators
Study Chair: Sandoz Biopharmaceutical Clinical Development Sandoz Biopharmaceuticals
  More Information

Publications:
Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01516736     History of Changes
Other Study ID Numbers: LA-EP06-302
First Submitted: January 13, 2012
First Posted: January 25, 2012
Results First Submitted: March 28, 2017
Results First Posted: June 28, 2017
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sandoz:
Pegfilgrastim
G-CSF
neutropenia
breast cancer
myelosuppressive chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neutropenia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases