A Study to Evaluate Efficacy and Safety of Epoetin Beta (NeoRecormon®) in Anemic Participants With Breast Cancer Undergoing Chemotherapy
NCT ID: NCT02761642
Last Updated: 2018-08-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
2004-02-29
2007-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Epoetin Beta
Anemic breast cancer participants will receive epoetin beta treatment for 12 weeks.
Epoetin Beta
All participants will receive epoetin beta at a dose of 30000 International Units (IU) as SC injection once every week for a total of 12 weeks. Adjustments in the dose will be implemented based on the participant's blood hemoglobin levels.
Interventions
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Epoetin Beta
All participants will receive epoetin beta at a dose of 30000 International Units (IU) as SC injection once every week for a total of 12 weeks. Adjustments in the dose will be implemented based on the participant's blood hemoglobin levels.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Arezzo, , Italy
Ascoli Piceno, , Italy
Bussolengo VR, , Italy
Busto Arsizio, , Italy
Casale Monferrato, , Italy
Catania, , Italy
Catanzaro, , Italy
Chieti, , Italy
Cuneo, , Italy
Fano, , Italy
Florence, , Italy
Frosinone, , Italy
Genova, , Italy
Macerata, , Italy
Messina, , Italy
Monza, , Italy
Napoli, , Italy
Nocera Inferiore, , Italy
Pavia, , Italy
Pisa, , Italy
Pordenone, , Italy
Roma, , Italy
Roma, , Italy
Sassari, , Italy
Torino, , Italy
Vecchiazzano, , Italy
Vittorio Veneto, , Italy
Countries
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Other Identifiers
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ML17503
Identifier Type: -
Identifier Source: org_study_id
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