A Randomized, Double-blind, Parallel-group, Multi-center Phase 3 Comparative Study Investigating Efficacy and Safety of LA-EP2006 and Neulasta® in Breast Cancer Patients Treated With Myelosuppressive Chemotherapy
- histologically proven breast cancer
- eligible for six cycles of neoadjuvant or adjuvant chemotherapy
- 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.
Type of Study:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Mean duration of Grade 4 neutropenia during Cycle 1 of chemotherapy
Mean duration of severe neutropenia, defined as number of consecutive days with Grade 4 neutropenia.
Outcome Time Frame:
21 days (Cycle 1 of chemotherapy treatment)
Karsten Roth, Dr.
Russia: Ministry of Health of the Russian Federation
- Neutropenic Complications
- Breast Cancer Patients Treated With Myelosuppressive Chemotherapy
- Prevention of neutropenic complications in breast cancer patients
- breast cancer,
- myelosuppressive chemotherapy,
- supportive care
- Breast Neoplasms