Trial record 1 of 3 for:
Sandoz, pegfilgrastim
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim (PROTECT2)
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| ClinicalTrials.gov Identifier: NCT01516736 |
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Recruitment Status :
Completed
First Posted : January 25, 2012
Results First Posted : June 28, 2017
Last Update Posted : August 30, 2017
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Sponsor:
Sandoz
Collaborator:
Sandoz GmbH
Information provided by (Responsible Party):
Sandoz
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Chemotherapy-induced Neutropenia Breast Cancer | Drug: LA-EP2006 Drug: Neulasta® | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 308 participants |
| 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® |
| Study Start Date : | March 2012 |
| Actual Primary Completion Date : | August 2013 |
| Actual Study Completion Date : | December 2013 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Pegfilgrastim
| Arm | Intervention/treatment |
|---|---|
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Experimental: LA-EP2006
During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
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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 |
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Active Comparator: Neulasta®
During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
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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:
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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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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.
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
Locations
Show 53 study locations
Sponsors and Collaborators
Sandoz
Sandoz GmbH
Investigators
| Study Chair: | Sandoz Biopharmaceutical Clinical Development | Sandoz Biopharmaceuticals |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sandoz |
| ClinicalTrials.gov Identifier: | NCT01516736 |
| Other Study ID Numbers: |
LA-EP06-302 |
| First Posted: | January 25, 2012 Key Record Dates |
| 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:
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Pegfilgrastim G-CSF neutropenia breast cancer myelosuppressive chemotherapy |
Additional relevant MeSH terms:
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Breast Neoplasms Neutropenia Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases |