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

Completed · Phase 3

Conditions studied: Chemotherapy-induced Neutropenia, Breast Cancer

In brief

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.

Key facts

Study ID

NCT01516736

Run by

Sandoz

People needed

308

Starts

2012-03-01

Expected to finish

2013-12-01

Last updated by the study team

2017-08-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Sandoz Investigational Site — Jonesboro, Arkansas, United States
• Sandoz Investigational Site — Corona, California, United States
• Sandoz Investigational Site — Wichita, Kansas, United States
• Sandoz Investigational Site — Mount Sterling, Kentucky, United States
• Sandoz Investigational Site — Detroit, Michigan, United States
• Sandoz Investigational Site — Bismarck, North Dakota, United States
• Sandoz Investigational Site — Eugene, Oregon, United States
• Sandoz Investigational Site — Germantown, Tennessee, United States
• Sandoz Investigational Site — Newport News, Virginia, United States
• Sandoz Investigational Site — San Miguel de Tucumán, Argentina
• Sandoz Investigational Site — Temuco, Chile
• 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 — Surat, India
• Sandoz Investigational Site — Vadodara, India
• Sandoz Investigational Site — Vellore, India
• Sandoz Investigational Site — Hot Springs, Arkansas, United States

Full record on ClinicalTrials.gov

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