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


Phase 3
18 Years
N/A
Open (Enrolling)
Female
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:

Interventional

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:

Yes

Authority:

United States: Federal Government

Study ID:

LA-EP06-302

NCT ID:

NCT01516736

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

Name

Location

Sandoz Investigational SiteJonesboro, Arkansas  72401
Sandoz Investigational SiteCorona, California  92879
Sandoz Investigational SiteMiami, Florida  33133
Sandoz Investigational SiteOak Lawn, Illinois  60453
Sandoz Investigational SiteWichita, Kansas  67214
Sandoz Investigational SiteMt Sterling, Kentucky  40353
Sandoz Investigational SiteBethesda, Maryland  20817
Sandoz Investigational SiteDetroit, Michigan  48202
Sandoz Investigational SiteBismarck, North Dakota  58501
Sandoz Investigational SiteEugene, Oregon  97401
Sandoz Investigational SiteGermantown, Tennessee  38138
Sandoz Investigational SiteNewport News, Virginia  23601