Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta® (PROTECT-1)

June 29, 2017 updated by: Sandoz

A Randomized, Double-blind, Parallel-group, Multi-center Phase 3 Comparative Study Investigating Efficacy and Safety of LA-EP2006 and Neulasta® in Breast Cancer Patients Treated With Myelosuppressive Chemotherapy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This randomized, double-blind trial compared the proposed biosimilar LA-EP2006 with the reference Neulasta® in women (≥18 years) receiving chemotherapy for breast cancer. Therefore patients were randomized to receive LA-EP2006 (n = 159) or the reference product (n = 157) for ≤6 cycles of (neo)-adjuvant TAC (docetaxel 75mg/m^2, doxorubicin 50 mg/m^2, and cyclophosphamide 500mg/m^2) chemotherapy. 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/l). The equivalence was confirmed if 95% CIs were within a ±1 day margin. LA-EP2006 was equivalent to the reference product in DSN (difference: 0.07 days; 95% CI [-0.12, 0.26]). Further, LA-EP2006 and the reference Neulasta® showed no clinically meaningful differences regarding efficacy and safety.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
316

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Ijui, Brazil, 98700-000
        • Sandoz Investigational Site
      • Lajeado, Brazil, 95900-000
        • Sandoz Investigational Site
      • Santo Andre, Brazil, 0960-650
        • Sandoz Investigational Site
  • India
      • Andhra Pradesh, India, 530002
        • Sandoz Investigational Site
      • Delhi, India, 110095
        • Sandoz Investigational Site
      • Madurai, India, 625107
        • Sandoz Investigational Site
      • Maharashtra, India, 411001
        • Sandoz Investigational Site
      • Maharashtra, India, 416008
        • Sandoz Investigational Site
      • Maharashtra, India, 440010
        • Sandoz Investigational Site
      • Mumbai, India, 422005
        • Sandoz Investigational Site
      • Rajasthan, India, 302013
        • Sandoz Investigational Site
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Sandoz Investigational Site
      • Juchitan, Mexico, 70000
        • Sandoz Investigational Site
  • Romania
      • Bucharest, Romania, 11461
        • Sandoz Investigational Site
      • Bucharest, Romania, 23423
        • Sandoz Investigational Site
      • Iasi, Romania, 700106
        • Sandoz Investigational Site
      • Suceava, Romania, 720237
        • Sandoz Investigational Site
  • Russian Federation
      • Barnaul, Russian Federation, 656052
        • Sandoz Investigational Site
      • Bashkortostan, Russian Federation, 450054
        • Sandoz Investigational Site
      • Berdsk, Russian Federation, 633004
        • Sandoz Investigational Site
      • Ivanovo, Russian Federation, 153040
        • Sandoz Investigational Site
      • Kabardino, Russian Federation, 361045
        • Sandoz Investigational Site
      • Kazan, Russian Federation, 420029
        • Sandoz Investigational Site
      • Krasnodar, Russian Federation, 354057
        • Sandoz Investigational Site
      • Kursk, Russian Federation, 305035
        • Sandoz Investigational Site
      • Leningrad, Russian Federation, 188663
        • Sandoz Investigational Site
      • Moscow, Russian Federation, 115478
        • Sandoz Investigational Site
      • Novgorod, Russian Federation, 173016
        • Sandoz Investigational Site
      • Oktyabrskaya, Russian Federation, 355047
        • Sandoz Investigational Site
      • Ryazan, Russian Federation, 390011
        • Sandoz Investigational Site
      • St. Petersburg, Russian Federation, 195067
        • Sandoz Investigational Site
      • Tula, Russian Federation, 300053
        • Sandoz Investigational Site
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • Sandoz Investigational Site
      • Chernivtsi, Ukraine, 58013
        • Sandoz Investigational Site
      • Dnipropetrovsk, Ukraine, 49102
        • Sandoz Investigational Site
      • Kharkiv, Ukraine, 61176
        • Sandoz Investigational Site
      • Kriviy Rig, Ukraine, 50048
        • Sandoz Investigational Site
      • Lugansk, Ukraine, 91000
        • Sandoz Investigational Site
      • Mariupol, Ukraine, 87500
        • Sandoz Investigational Site
      • Vinnytsya, Ukraine, 21029
        • Sandoz Investigational Site
      • Zaporizhzhia, Ukraine, 69040
        • Sandoz Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 pegfilgrastim is injected s.c. post chemotherapy application.
Other Names:
  • pegfilgrastim
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 pegfilgrastim is injected s.c. post chemotherapy application.
Other Names:
  • pegfilgrastim

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 cells/L (grade 4 neutropenia).
21 days (Cycle 1 of chemotherapy treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Cycle 1 (3 weeks)
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".
across all cycles (18 weeks)
Incidence of Febrile Neutropenia (FN)
Time Frame: across all cycles (18 weeks)
FN was defined as an 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.
across all cycles (18 weeks)
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 temperature ≥ 38.3°C. Fever episodes were characterized by maximum oral temperature and the number of patients who had fever at least once.
across al cycles (18 weeks)
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. Only the evaluable patients with a depth of ANC in Cycle 1 are given.
Cycle 1 (3 weeks)
Time to ANC Recovery in Days in Cycle 1
Time Frame: across Cycle 1 (3 weeks)
Time to absolute neutrophil count (ANC) recovery in Cycle 1 was defined as the time in days from ANC nadir until the patient's ANC had increased to ≥ 2 × 10^9 cells/L. Only the evaluable patients with a depth of ANC in Cycle 1 and a later increase of ANC ≥ 2 × 10^9 cells/L are given.
across Cycle 1 (3 weeks)
Mortality Due to Infection
Time Frame: Study course (41 weeks)
Number of patients with death due to infections
Study course (41 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sandoz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sandoz GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Sandoz Biopharmaceutical Clinical Development, Sandoz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LA-EP06-301
  • 2011-004532-58 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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