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

Phase 3
18 Years
Open (Enrolling)
Chemotherapy-induced Neutropenia, Breast Cancer

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Trial Information

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

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.

Type of Study:


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

Outcome Measure:

Mean duration of Grade 4 neutropenia during Cycle 1 of chemotherapy

Outcome Description:

Mean duration of severe neutropenia, defined as number of consecutive days with Grade 4 neutropenia.

Outcome Time Frame:

21 days (Cycle 1 of chemotherapy treatment)

Safety Issue:



United States: Federal Government

Study ID:




Start Date:

December 2011

Completion Date:

June 2013

Related Keywords:

  • Chemotherapy-Induced Neutropenia
  • Breast Cancer
  • Pegfilgrastim
  • G-CSF
  • neutropenia
  • breast cancer
  • myelosuppressive chemotherapy
  • Breast Neoplasms
  • Neutropenia



Sandoz Investigational Site Jonesboro, Arkansas  72401
Sandoz Investigational Site Corona, California  92879
Sandoz Investigational Site Miami, Florida  33133
Sandoz Investigational Site Oak Lawn, Illinois  60453
Sandoz Investigational Site Wichita, Kansas  67214
Sandoz Investigational Site Mt Sterling, Kentucky  40353
Sandoz Investigational Site Bethesda, Maryland  20817
Sandoz Investigational Site Detroit, Michigan  48202
Sandoz Investigational Site Bismarck, North Dakota  58501
Sandoz Investigational Site Eugene, Oregon  97401
Sandoz Investigational Site Germantown, Tennessee  38138
Sandoz Investigational Site Newport News, Virginia  23601