Pivotal Study in Breast Cancer Patients Investigating Efficacy and Safety of LA-EP2006 and Neulasta®
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Chemotherapy-induced Neutropenia, Breast Cancer
Female
Chemotherapy-induced Neutropenia, Breast Cancer
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 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 |
