A study to evaluate the Efficacy and Safety of LA-EP2006 and Neulasta® in patients with breast cancer.
Phase 3
Completed
- Conditions
- Health Condition 1: null- Prevention of neutropenic complications in breast cancer patients treated with myelosuppressive chemotherapy
- Registration Number
- CTRI/2012/09/003030
- Lead Sponsor
- Sandoz GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 302
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method