Status:
COMPLETED
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim
Lead Sponsor:
Sandoz
Collaborating Sponsors:
Sandoz GmbH
Conditions:
Chemotherapy-induced Neutropenia
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patie...
Detailed Description
The Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2) was a confirmatory efficacy and safety study designed to compare the proposed biosimilar LA-...
Eligibility Criteria
Inclusion
- histologically proven breast cancer
- eligible for six cycles of neoadjuvant or adjuvant chemotherapy
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT01516736
Start Date
March 1 2012
End Date
December 1 2013
Last Update
August 30 2017
Active Locations (53)
Enter a location and click search to find clinical trials sorted by distance.
1
Sandoz Investigational Site
Hot Springs, Arkansas, United States, 71913
2
Sandoz Investigational Site
Jonesboro, Arkansas, United States, 72401
3
Sandoz Investigational Site
Corona, California, United States, 92879
4
Sandoz Investigational Site
Wichita, Kansas, United States, 67214