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NCT01516736 Clinical Trial

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

Breast Cancer Clinical Trial

— PROTECT2  

Official title:
Pivotal Study in Breast Cancer Patients Investigating Efficacy and Safety of LA-EP2006 and Neulasta®

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01516736
Other study ID # LA-EP06-302
Secondary ID
Status Completed
Phase Phase 3
First received January 13, 2012
Last updated September 7, 2015
Start date March 2012
Est. completion date December 2013

Study information
Verified date September 2015
Source Sandoz
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The study will assess the efficacy of LA-EP2006 compared to Peg-Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

Recruitment information / eligibility
Status Completed
Enrollment 308
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Drug:
• 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.
• Peg-Filgrastim
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.
• Docetaxel

• Doxorubicin

• Cyclophosphamide

Locations
Country Name City State
Argentina Sandoz Investigational Site Tucuman
Chile Sandoz Investigational Site Temuco
India Sandoz Investigational Site Chennai
India Sandoz Investigational Site Delhi
India Sandoz Investigational Site Gujarat
India Sandoz Investigational Site Hyderabad
India Sandoz Investigational Site Karamsad
India Sandoz Investigational Site Lucknow
India Sandoz Investigational Site Maharashtra
India Sandoz Investigational Site Mangalore
India Sandoz Investigational Site Mumbai
India Sandoz Investigational Site Pradesh
India Sandoz Investigational Site Saroli
India Sandoz Investigational Site Vadodara
India Sandoz Investigational Site Vellore
India Sandoz Investigational Site Visakhapatnam
Malaysia Sandoz Investigational Site Kelantan
Malaysia Sandoz Investigational Site Nilai
Malaysia Sandoz Investigational Site Penang
Malaysia Sandoz Investigational Site Penang
Puerto Rico Sandoz Investigational Site San Juan
Puerto Rico Sandoz Investigational Site San Juan
Russian Federation Sandoz Investigational Site Bashkortostan
Russian Federation Sandoz Investigational Site Bryansk
Russian Federation Sandoz Investigational Site Kazan
Russian Federation Sandoz Investigational Site Krasnoyarsk
Russian Federation Sandoz Investigational Site Moscow
Russian Federation Sandoz Investigational Site Omsk
Russian Federation Sandoz Investigational Site Orel
Russian Federation Sandoz Investigational Site Orenburg
Russian Federation Sandoz Investigational Site Rostov-na-Donu
Russian Federation Sandoz Investigational Site St Petersburg
Russian Federation Sandoz Investigational Site St. Petersburg
Russian Federation Sandoz Investigational Site St. Petersburg
Russian Federation Sandoz Investigational Site St. Petersburg
Russian Federation Sandoz Investigational Site St. Petersburg
Russian Federation Sandoz Investigational Site Tomsk
Russian Federation Sandoz Investigational Site Vladimir
Spain Sandoz Investigational Site Barcelona
Spain Sandoz Investigational Site Madrid
Spain Sandoz Investigational Site Santiago de Compostela
Spain Sandoz Investigational Site Valencia
United States Sandoz Investigational Site Bethesda Maryland
United States Sandoz Investigational Site Bismarck North Dakota
United States Sandoz Investigational Site Corona California
United States Sandoz Investigational Site Detroit Michigan
United States Sandoz Investigational Site Eugene Oregon
United States Sandoz Investigational Site Evergreen Park Illinois
United States Sandoz Investigational Site Fountain Valley California
United States Sandoz Investigational Site Germantown Tennessee
United States Sandoz Investigational Site Hot Springs Arkansas
United States Sandoz Investigational Site Jonesboro Arkansas
United States Sandoz Investigational Site Miami Florida
United States Sandoz Investigational Site Mt Sterling Kentucky
United States Sandoz Investigational Site Newport News Virginia
United States Sandoz Investigational Site Park Ridge Illinois
United States Sandoz Investigational Site Riverside California
United States Sandoz Investigational Site Skokie Illinois
United States Sandoz Investigational Site Wichita Kansas

Sponsors (1)
Lead Sponsor Collaborator
Sandoz

Countries where clinical trial is conducted

United States,  Argentina,  Chile,  India,  Malaysia,  Puerto Rico,  Russian Federation,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean duration of Grade 4 neutropenia during Cycle 1 of chemotherapy Mean duration of severe neutropenia, defined as number of consecutive days with Grade 4 neutropenia. 21 days (Cycle 1 of chemotherapy treatment) Yes
Secondary Incidence of febrile neutropenia to assess the safety of LA-EP2006 and Peg-Filgrastim 4 months Yes
Secondary Incidence, occurrence and severity of (serious) adverse events. 21 weeks Yes
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