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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 SiteJonesboro, Arkansas  72401
Sandoz Investigational SiteCorona, California  92879
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