Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta®

• Status: Completed
• Trial end date: 2014-02-01
• 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: 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.