Status:
COMPLETED
Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim
Lead Sponsor:
Sandoz
Conditions:
Chemotherapy Associated Neutropenia
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
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 patient...
Eligibility Criteria
Inclusion
- Patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant myelosuppressive chemotherapy
- Women ≥ 18 years of age
- Estimated life expectancy of more than six months
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT01519700
Start Date
December 1 2011
End Date
June 1 2013
Last Update
May 6 2015
Active Locations (26)
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1
Insitut Onkologie a Rehabilitaca na Plesi
Ves Pod Plesi 110, Czechia, 26204
2
Semmelweis Egyetem, III. Belgyogyaszati Klinika
Budapest, Hungary, 1125
3
Fovarosi Onkormanyzat Uzsoki utcai Korhaz, Onkoradiologia
Budapest, Hungary, 1145
4
DE OEC, Onkologiai Tanszek
Debrecen, Hungary, 4032