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

NCT01516736 | Completed Phase 3 Results DMC

• 1 other identifier: LA-EP06-302
• Study Type: interventional
• Target: 308
• Locations: 8 countries
• Sites: 53

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.

Conditions

Chemotherapy-induced Neutropenia; Breast Cancer

Keywords

Pegfilgrastim; G-CSF; neutropenia; breast cancer; myelosuppressive chemotherapy

Outcome Measures

Primary Outcomes (1)

• Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy

  Mean duration of severe neutropenia, defined as number of consecutive days with ANC \<0.5 × 10\^9/l (grade 4 neutropenia).

  21 days (Cycle 1 of chemotherapy treatment)

Secondary Outcomes (7)

• Incidence of Febrile Neutropenia (FN)

  across all cycles (18 weeks)

• Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles

  across al cycles (18 weeks)

• Depth of ANC Nadir in Cycle 1

  Cycle 1 (3 weeks)

• Number of Patients With ANC Nadir Per Day in Cycle 1

  Cycle 1 (3 weeks)

• Time to ANC Recovery in Days in Cycle 1

  across Cycle 1 (3 weeks)

Study Arms (2)

LA-EP2006

EXPERIMENTAL

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

Drug: LA-EP2006

Neulasta®

ACTIVE COMPARATOR

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

Drug: Neulasta®

Interventions

LA-EP2006 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.

Also known as: pegfilgrastim

LA-EP2006

Neulasta® 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.

Also known as: pegfilgrastim, Neulasta

Neulasta®

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically proven breast cancer
• eligible for six cycles of neoadjuvant or adjuvant chemotherapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Sandoz: lead
• Sandoz GmbH: collaborator

Study Sites (53)

Sandoz Investigational Site

Hot Springs, Arkansas, 71913, United States

Location

Sandoz Investigational Site

Jonesboro, Arkansas, 72401, United States

Location

Sandoz Investigational Site

Corona, California, 92879, United States

Location

Sandoz Investigational Site

Wichita, Kansas, 67214, United States

Location

Sandoz Investigational Site

Mount Sterling, Kentucky, 40353, United States

Location

Sandoz Investigational Site

Detroit, Michigan, 48202, United States

Location

Sandoz Investigational Site

Bismarck, North Dakota, 58501, United States

Location

Sandoz Investigational Site

Eugene, Oregon, 97401, United States

Location

Sandoz Investigational Site

Germantown, Tennessee, 38138, United States

Location

Sandoz Investigational Site

Newport News, Virginia, 23601, United States

Location

Sandoz Investigational Site

San Miguel de Tucumán, 4000, Argentina

Location

Sandoz Investigational Site

Temuco, 4810469, Chile

Location

Sandoz Investigational Site

Chennai, 600031, India

Location

Sandoz Investigational Site

Delhi, 110092, India

Location

Sandoz Investigational Site

Gujarat, 380009, India

Location

Sandoz Investigational Site

Hyderabad, 50024, India

Location

Sandoz Investigational Site

Karamsad, 388325, India

Location

Sandoz Investigational Site

Lucknow, 226003, India

Location

Sandoz Investigational Site

Maharashtra, 422004, India

Location

Sandoz Investigational Site

Mangalore, 575001, India

Location

Sandoz Investigational Site

Mumbai, 400010, India

Location

Sandoz Investigational Site

Pradesh, 520002, India

Location

Sandoz Investigational Site

Surat, 395010, India

Location

Sandoz Investigational Site

Vadodara, 391760, India

Location

Sandoz Investigational Site

Vellore, 632004, India

Location

Sandoz Investigational Site

Visakhapatnam, 530017, India

Location

Sandoz Investigational Site

George Town, 11200, Malaysia

Location

Sandoz Investigational Site

George Town, 11600, Malaysia

Location

Sandoz Investigational Site

Kampung Baharu Nilai, 71800, Malaysia

Location

Sandoz Investigational Site

Kelantan, 16150, Malaysia

Location

Sandoz Investigational Site

San Juan, 00910, Puerto Rico

Location

Sandoz Investigational Site

San Juan, 00927, Puerto Rico

Location

Sandoz Investigational Site

Arkhangelsk, 163045, Russia

Location

Sandoz Investigational Site

Bashkortostan, 450054, Russia

Location

Sandoz Investigational Site

Bryansk, 241033, Russia

Location

Sandoz Investigational Site

Kazan', 420029, Russia

Location

Sandoz Investigational Site

Krasnoyarsk, 660133, Russia

Location

Sandoz Investigational Site

Moscow, 115478, Russia

Location

Sandoz Investigational Site

Omsk, 644046, Russia

Location

Sandoz Investigational Site

Orenburg, 460021, Russia

Location

Sandoz Investigational Site

Oryol, 302020, Russia

Location

Sandoz Investigational Site

Rostov-on-Don, 344037, Russia

Location

Sandoz Investigational Site

Saint Petersburg, 194017, Russia

Location

Sandoz Investigational Site

Saint Petersburg, 194044, Russia

Location

Sandoz Investigational Site

Saint Petersburg, 195271, Russia

Location

Sandoz Investigational Site

Saint Petersburg, 197022, Russia

Location

Sandoz Investigational Site

Saint Petersburg, 197758, Russia

Location

Sandoz Investigational Site

Tomsk, 634009, Russia

Location

Sandoz Investigational Site

Vladimir, 600021, Russia

Location

Sandoz Investigational Site

Barcelona, 08035, Spain

Location

Sandoz Investigational Site

Madrid, 28040, Spain

Location

Sandoz Investigational Site

Santiago de Compostela, 15706, Spain

Location

Sandoz Investigational Site

Valencia, 46014, Spain

Location

Related Publications (2)

• 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.

  PMID: 27091420 BACKGROUND

• 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.

  PMID: 28637287 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Neutropenia

Interventions

pegfilgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Results Point of Contact

• Title: Strategic Planning, Biopharmaceutical Clinical Development
• Organization: Sandoz

biopharma.clinicaltrials@sandoz.com

+49 (0) 8024 476 - 0

Study Officials

• Sandoz Biopharmaceutical Clinical Development

  Sandoz Biopharmaceuticals

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: January 25, 2012
• Study Start: March 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 30, 2017
• Results First Posted: June 28, 2017

Record last verified: 2017-08

Locations

US (10); AR (1); PR (2); ES (4); CL (1); IN (14); MY (4); RU (17)