Status:
COMPLETED
A Study to Evaluate Efficacy and Safety of Epoetin Beta (NeoRecormon®) in Anemic Participants With Breast Cancer Undergoing Chemotherapy
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Anemia
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the efficacy and safety of subcutaneous (SC) epoetin beta in anemic participants with breast cancer undergoing chemotherapy.
Eligibility Criteria
Inclusion
- Adult female participants with histological diagnosis of breast cancer
- Any type of chemotherapy planned for greater than or equal to (\>/=) 9 weeks
- Hemoglobin level less than (\<) 11 grams per deciliter (g/dL)
- Participants able to receive iron supplement, if necessary
Exclusion
- Known or suspected contraindications to epoetin beta
- Pregnancy or lactation period
- Diagnosis of anemia only due to iron-deficiency
- Diagnosis of thalasemic syndromes
- Epilepsy and/or cerebral metastasis
- Blood transfusion or treatment with any erythropoietic factor within 4 weeks before study start
Key Trial Info
Start Date :
February 29 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2007
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02761642
Start Date
February 29 2004
End Date
March 31 2007
Last Update
August 24 2018
Active Locations (27)
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1
Arezzo, Italy, 52100
2
Ascoli Piceno, Italy, 63100
3
Bussolengo VR, Italy, 37012
4
Busto Arsizio, Italy, 21052