CTRI/2012/10/003065
Completed
Phase 3
Pivotal study in breast cancer patients investigating efficacy and safety of LA-EP2006 and Neulasta®. - PROTECT-2
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sandoz GmbH
- Enrollment
- 302
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. histologically proven breast cancer
- •2\. eligible for six cycles of neoadjuvant or adjuvant chemotherapy
Exclusion Criteria
- •1\. History of cancer
- •2\. Active infection
- •3\. Known immunodeficiency syndrome
- •4\. Previous therapy with any G\-CSF (granulocyte\-colony stimulating factor) product
- •Other protocol\-defined inclusion/exclusion criteria may apply.
Outcomes
Primary Outcomes
Not specified
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