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

NCT ID: NCT01735175

Last Updated: 2017-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 316 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-02-28

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

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 pegfilgrastim is injected s.c. post chemotherapy application.

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 pegfilgrastim is injected s.c. post chemotherapy application.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

pegfilgrastim; pegfilgrastim

Eligibility Criteria

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

Sandoz GmbH

INDUSTRY

Sponsor Role: collaborator

Sandoz

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandoz Biopharmaceutical Clinical Development

Role: STUDY_CHAIR

Sandoz

Locations

Sandoz Investigational Site

Ijuí, , Brazil

Sandoz Investigational Site

Lajeado, , Brazil

Sandoz Investigational Site

Santo André, , Brazil

Sandoz Investigational Site

Andhra Pradesh, , India

Sandoz Investigational Site

Delhi, , India

Sandoz Investigational Site

Madurai, , India

Sandoz Investigational Site

Maharashtra, , India

Sandoz Investigational Site

Maharashtra, , India

Sandoz Investigational Site

Maharashtra, , India

Sandoz Investigational Site

Mumbai, , India

Sandoz Investigational Site

Rajasthan, , India

Sandoz Investigational Site

Aguascalientes, , Mexico

Sandoz Investigational Site

Juchitán, , Mexico

Sandoz Investigational Site

Bucharest, , Romania

Sandoz Investigational Site

Bucharest, , Romania

Sandoz Investigational Site

Iași, , Romania

Sandoz Investigational Site

Suceava, , Romania

Sandoz Investigational Site

Barnaul, , Russia

Sandoz Investigational Site

Bashkortostan, , Russia

Sandoz Investigational Site

Berdsk, , Russia

Sandoz Investigational Site

Ivanovo, , Russia

Sandoz Investigational Site

Kabardino, , Russia

Sandoz Investigational Site

Kazan', , Russia

Sandoz Investigational Site

Krasnodar, , Russia

Sandoz Investigational Site

Kursk, , Russia

Sandoz Investigational Site

Moscow, , Russia

Sandoz Investigational Site

Oktyabrskaya, , Russia

Sandoz Investigational Site

Ryazan, , Russia

Sandoz Investigational Site

Saint Petersburg, , Russia

Sandoz Investigational Site

Saint Petersburg, , Russia

Sandoz Investigational Site

Tula, , Russia

Sandoz Investigational Site

Veliky Novgorod, , Russia

Sandoz Investigational Site

Cherkasy, , Ukraine

Sandoz Investigational Site

Chernivtsi, , Ukraine

Sandoz Investigational Site

Dnipropetrovsk, , Ukraine

Sandoz Investigational Site

Kharkiv, , Ukraine

Sandoz Investigational Site

Kryvyi Rih, , Ukraine

Sandoz Investigational Site

Luhansk, , Ukraine

Sandoz Investigational Site

Mariupol, , Ukraine

Sandoz Investigational Site

Vinnytsia, , Ukraine

Sandoz Investigational Site

Zaporizhzhia, , Ukraine

Countries

Brazil; India; Mexico; Romania; Russia; Ukraine

References

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.

Reference Type: RESULT

PMID: 27020170 (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

2011-004532-58

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LA-EP06-301

Identifier Type: -

Identifier Source: org_study_id