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Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim

NCT ID: NCT01516736

Last Updated: 2017-08-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chemotherapy-induced Neutropenia Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LA-EP2006

During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.

Group Type EXPERIMENTAL

LA-EP2006

Intervention Type DRUG

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.

Neulasta®

During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.

Group Type ACTIVE_COMPARATOR

Neulasta®

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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pegfilgrastim pegfilgrastim Neulasta

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sandoz GmbH

INDUSTRY

Sponsor Role collaborator

Sandoz

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandoz Biopharmaceutical Clinical Development

Role: STUDY_CHAIR

Sandoz Biopharmaceuticals

Locations

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Sandoz Investigational Site

Hot Springs, Arkansas, United States

Site Status

Sandoz Investigational Site

Jonesboro, Arkansas, United States

Site Status

Sandoz Investigational Site

Corona, California, United States

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Sandoz Investigational Site

Wichita, Kansas, United States

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Sandoz Investigational Site

Mount Sterling, Kentucky, United States

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Detroit, Michigan, United States

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Sandoz Investigational Site

Bismarck, North Dakota, United States

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Sandoz Investigational Site

Eugene, Oregon, United States

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Sandoz Investigational Site

Germantown, Tennessee, United States

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Sandoz Investigational Site

Newport News, Virginia, United States

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Sandoz Investigational Site

San Miguel de Tucumán, , Argentina

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Sandoz Investigational Site

Temuco, , Chile

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Sandoz Investigational Site

Chennai, , India

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Sandoz Investigational Site

Delhi, , India

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Sandoz Investigational Site

Gujarat, , India

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Sandoz Investigational Site

Hyderabad, , India

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Sandoz Investigational Site

Karamsad, , India

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Sandoz Investigational Site

Lucknow, , India

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Sandoz Investigational Site

Maharashtra, , India

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Sandoz Investigational Site

Mangalore, , India

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Sandoz Investigational Site

Mumbai, , India

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Sandoz Investigational Site

Pradesh, , India

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Sandoz Investigational Site

Surat, , India

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Sandoz Investigational Site

Vadodara, , India

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Sandoz Investigational Site

Vellore, , India

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Sandoz Investigational Site

Visakhapatnam, , India

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Sandoz Investigational Site

George Town, , Malaysia

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Sandoz Investigational Site

George Town, , Malaysia

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Sandoz Investigational Site

Kampung Baharu Nilai, , Malaysia

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Sandoz Investigational Site

Kelantan, , Malaysia

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Sandoz Investigational Site

San Juan, , Puerto Rico

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Sandoz Investigational Site

San Juan, , Puerto Rico

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Sandoz Investigational Site

Arkhangelsk, , Russia

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Sandoz Investigational Site

Bashkortostan, , Russia

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Sandoz Investigational Site

Bryansk, , Russia

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Sandoz Investigational Site

Kazan', , Russia

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Sandoz Investigational Site

Krasnoyarsk, , Russia

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Moscow, , Russia

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Sandoz Investigational Site

Omsk, , Russia

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Sandoz Investigational Site

Orenburg, , Russia

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Sandoz Investigational Site

Oryol, , Russia

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Sandoz Investigational Site

Rostov-on-Don, , Russia

Site Status

Sandoz Investigational Site

Saint Petersburg, , Russia

Site Status

Sandoz Investigational Site

Saint Petersburg, , Russia

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Sandoz Investigational Site

Saint Petersburg, , Russia

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Sandoz Investigational Site

Saint Petersburg, , Russia

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Sandoz Investigational Site

Saint Petersburg, , Russia

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Sandoz Investigational Site

Tomsk, , Russia

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Sandoz Investigational Site

Vladimir, , Russia

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Sandoz Investigational Site

Barcelona, , Spain

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Sandoz Investigational Site

Madrid, , Spain

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Sandoz Investigational Site

Santiago de Compostela, , Spain

Site Status

Sandoz Investigational Site

Valencia, , Spain

Site Status

Countries

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United States Argentina Chile India Malaysia Puerto Rico Russia Spain

References

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Blackwell K, Donskih R, Jones CM, Nixon A, Vidal MJ, Nakov R, Singh P, Schaffar G, Gascon 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.

Reference Type BACKGROUND
PMID: 27091420 (View on PubMed)

Blackwell K, Gascon P, Jones CM, Nixon A, Krendyukov A, Nakov R, Li Y, Harbeck N. Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer. Ann Oncol. 2017 Sep 1;28(9):2272-2277. doi: 10.1093/annonc/mdx303.

Reference Type DERIVED
PMID: 28637287 (View on PubMed)

Other Identifiers

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LA-EP06-302

Identifier Type: -

Identifier Source: org_study_id

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