Overview

Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim

Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
Female
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 patients.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sandoz
Collaborator:
Sandoz GmbH
Treatments:
Cyclophosphamide
Doxorubicin
Lenograstim
Criteria
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.