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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

316

Phase

  • 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

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
Intervention / Treatment
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

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

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

Sandoz

Collaborators

Sandoz GmbH

Investigators

  • 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

June 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

November 22, 2012

First Submitted That Met QC Criteria

November 27, 2012

First Posted (Estimate)

November 28, 2012

Study Record Updates

Last Update Posted (Actual)

August 7, 2017

Last Update Submitted That Met QC Criteria

June 29, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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