Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim (PROTECT2)
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|ClinicalTrials.gov Identifier: NCT01516736|
Recruitment Status : Completed
First Posted : January 25, 2012
Results First Posted : June 28, 2017
Last Update Posted : August 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chemotherapy-induced Neutropenia Breast Cancer||Drug: LA-EP2006 Drug: Neulasta®||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||308 participants|
|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®|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||December 2013|
During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
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.
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.
- 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).
- 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
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
|Study Chair:||Sandoz Biopharmaceutical Clinical Development||Sandoz Biopharmaceuticals|