Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim

A Randomized, Double-blind, Parallel-group, Multi-center Phase III Study Comparing the Efficacy and Safety of EP2006 and Neupogen® in Breast Cancer Patients Treated With Myelosuppressive Chemotherapy

The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

Inclusion Criteria:

1. Patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant myelosuppressive chemotherapy
2. Women ≥ 18 years of age
3. Estimated life expectancy of more than six months

Exclusion Criteria:

1. Previous or concurrent malignancy except non-invasive non-melanoma skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least ten years prior to study entry
2. Any serious illness or medical condition that may interfere with safety, compliance, response to the products under investigation and their evaluation, e.g.:

Other protocol-defined inclusion/exclusion criteria may apply.