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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:
Collaborator:
Sandoz GmbH
Information provided by (Responsible Party):
Sandoz
ClinicalTrials.gov Identifier:
NCT01516736
First received: January 13, 2012
Last updated: June 29, 2017
Last verified: June 2017
January 13, 2012
June 29, 2017
March 2012
August 2013   (Final data collection date for primary outcome measure)
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).
Mean duration of Grade 4 neutropenia 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 Grade 4 neutropenia.
Complete list of historical versions of study NCT01516736 on ClinicalTrials.gov Archive Site
  • 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
  • Incidence of febrile neutropenia [ Time Frame: 4 months ]
    to assess the safety of LA-EP2006 and Peg-Filgrastim
  • Incidence, occurrence and severity of (serious) adverse events. [ Time Frame: 21 weeks ]
Not Provided
Not Provided
 
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim
Pivotal Study in Breast Cancer Patients Investigating 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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Chemotherapy-induced Neutropenia
  • Breast Cancer
  • 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
  • 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
  • Experimental: LA-EP2006
    During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
    Intervention: Drug: LA-EP2006
  • Active Comparator: Neulasta®
    During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
    Intervention: Drug: Neulasta®
Blackwell K, Donskih R, Jones CM, Nixon A, Vidal MJ, Nakov R, Singh P, Schaffar G, Gascón P, Harbeck N. A Comparison of Proposed Biosimilar LA-EP2006 and Reference Pegfilgrastim for the Prevention of Neutropenia in Patients With Early-Stage Breast Cancer Receiving Myelosuppressive Adjuvant or Neoadjuvant Chemotherapy: Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2), a Phase III, Randomized, Double-Blind Trial. Oncologist. 2016 Jul;21(7):789-94. doi: 10.1634/theoncologist.2016-0011. Epub 2016 Apr 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
308
December 2013
August 2013   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Chile,   India,   Malaysia,   Puerto Rico,   Russian Federation,   Spain,   United States
 
 
NCT01516736
LA-EP06-302
Yes
Not Provided
Plan to Share IPD: Undecided
Sandoz
Sandoz
Sandoz GmbH
Study Chair: Sandoz Biopharmaceutical Clinical Development Sandoz Biopharmaceuticals
Sandoz
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP