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



Status:Completed
Conditions:Breast Cancer, Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2012
End Date:December 2013

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.


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.
We found this trial at
18
sites
Sandoz Investigational Site
Eugene, Oregon 97401
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Eugene, OR
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Sandoz Investigational Site
Bethesda, Maryland 20817
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Bethesda, MD
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Sandoz Investigational Site
Bismarck, North Dakota 58501
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Bismarck, ND
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Sandoz Investigational Site
Corona, California 92879
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Corona, CA
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Sandoz Investigational Site
Detroit, Michigan 48202
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Detroit, MI
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Sandoz Investigational Site
Evergreen Park, Illinois 60805
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Evergreen Park, IL
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Sandoz Investigational Site
Fountain Valley, California 92708
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Fountain Valley, CA
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Sandoz Investigational Site
Germantown, Tennessee 38138
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Germantown, TN
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Sandoz Investigational Site
Hot Springs, Arkansas 71913
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Hot Springs, AR
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Sandoz Investigational Site
Jonesboro, Arkansas 72401
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Jonesboro, AR
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Sandoz Investigational Site
Miami, Florida 33133
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Miami, FL
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Sandoz Investigational Site
Mt Sterling, Kentucky 40353
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Mt Sterling, KY
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Sandoz Investigational Site
Newport News, Virginia 23601
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Newport News, VA
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Sandoz Investigational Site
Park Ridge, Illinois 60068
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Park Ridge, IL
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Sandoz Investigational Site
Riverside, California 92507
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Riverside, CA
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Sandoz Investigational Site
Skokie, Illinois 60076
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Skokie, IL
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Sandoz Investigational Site
Tucuman,
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Tucuman,
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Sandoz Investigational Site
Wichita, Kansas 67214
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Wichita, KS
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