Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta®

NCT01735175 | Completed Phase 3 Results DMC

• 2 other identifiers: LA-EP06-3012011-004532-58
• Study Type: interventional
• Target: 316
• Locations: 6 countries
• Sites: 41

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

Neutropenic Complications; Breast Neoplasms; Chemotherapy-induced Neutropenia; Chemotherapeutic Toxicity

Keywords

biosimilars; Pegfilgrastim,; G-CSF,; neutropenia,; breast cancer,; myelosuppressive chemotherapy,; supportive care; granulocyte-colony-stimulating factor

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 cells/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)

Neulasta®

ACTIVE COMPARATOR

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

Drug: Neulasta®

LA-EP2006

EXPERIMENTAL

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

Drug: LA-EP2006

Interventions

LA-EP2006 DRUG

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.

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 pegfilgrastim is injected s.c. post chemotherapy application.

Also known as: pegfilgrastim

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 (41)

Sandoz Investigational Site

Ijuí, 98700-000, Brazil

Location

Sandoz Investigational Site

Lajeado, 95900-000, Brazil

Location

Sandoz Investigational Site

Santo André, 0960-650, Brazil

Location

Sandoz Investigational Site

Andhra Pradesh, 530002, India

Location

Sandoz Investigational Site

Delhi, 110095, India

Location

Sandoz Investigational Site

Madurai, 625107, India

Location

Sandoz Investigational Site

Maharashtra, 411001, India

Location

Sandoz Investigational Site

Maharashtra, 416008, India

Location

Sandoz Investigational Site

Maharashtra, 440010, India

Location

Sandoz Investigational Site

Mumbai, 422005, India

Location

Sandoz Investigational Site

Rajasthan, 302013, India

Location

Sandoz Investigational Site

Aguascalientes, 20230, Mexico

Location

Sandoz Investigational Site

Juchitán, 70000, Mexico

Location

Sandoz Investigational Site

Bucharest, 11461, Romania

Location

Sandoz Investigational Site

Bucharest, 23423, Romania

Location

Sandoz Investigational Site

Iași, 700106, Romania

Location

Sandoz Investigational Site

Suceava, 720237, Romania

Location

Sandoz Investigational Site

Barnaul, 656052, Russia

Location

Sandoz Investigational Site

Bashkortostan, 450054, Russia

Location

Sandoz Investigational Site

Berdsk, 633004, Russia

Location

Sandoz Investigational Site

Ivanovo, 153040, Russia

Location

Sandoz Investigational Site

Kabardino, 361045, Russia

Location

Sandoz Investigational Site

Kazan', 420029, Russia

Location

Sandoz Investigational Site

Krasnodar, 354057, Russia

Location

Sandoz Investigational Site

Kursk, 305035, Russia

Location

Sandoz Investigational Site

Moscow, 115478, Russia

Location

Sandoz Investigational Site

Oktyabrskaya, 355047, Russia

Location

Sandoz Investigational Site

Ryazan, 390011, Russia

Location

Sandoz Investigational Site

Saint Petersburg, 188663, Russia

Location

Sandoz Investigational Site

Saint Petersburg, 195067, Russia

Location

Sandoz Investigational Site

Tula, 300053, Russia

Location

Sandoz Investigational Site

Veliky Novgorod, 173016, Russia

Location

Sandoz Investigational Site

Cherkasy, 18009, Ukraine

Location

Sandoz Investigational Site

Chernivtsi, 58013, Ukraine

Location

Sandoz Investigational Site

Dnipropetrovsk, 49102, Ukraine

Location

Sandoz Investigational Site

Kharkiv, 61176, Ukraine

Location

Sandoz Investigational Site

Kryvyi Rih, 50048, Ukraine

Location

Sandoz Investigational Site

Luhansk, 91000, Ukraine

Location

Sandoz Investigational Site

Mariupol, 87500, Ukraine

Location

Sandoz Investigational Site

Vinnytsia, 21029, Ukraine

Location

Sandoz Investigational Site

Zaporizhzhia, 69040, Ukraine

Location

Related Publications (2)

• Harbeck N, Lipatov O, Frolova M, Udovitsa D, Topuzov E, Ganea-Motan DE, Nakov R, Singh P, Rudy A, Blackwell K. Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer. Future Oncol. 2016 Jun;12(11):1359-67. doi: 10.2217/fon-2016-0016. Epub 2016 Mar 29.

  PMID: 27020170 RESULT

• 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

  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: November 22, 2012
• First Posted: November 28, 2012
• Study Start: June 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: February 1, 2014
• Last Updated: August 7, 2017
• Results First Posted: June 15, 2017

Record last verified: 2017-06

Locations

BR (3); ME (2); RO (4); IN (8); RU (15); UA (9)