Clinical trial · Interventional
A Study to Evaluate Efficacy and Safety of Epoetin Beta (NeoRecormon®) in Anemic Participants With Breast Cancer Undergoing Chemotherapy
Multicenter Study for the Evaluation of Efficacy and Safety of NeoRecormon® Therapy Administered as 30000 IU Subcutaneously in Anemic Patients With Breast Cancer Treated With Chemotherapy
NCT02761642CI-TRIAL-00034565completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will evaluate the efficacy and safety of subcutaneous (SC) epoetin beta in anemic participants with breast cancer undergoing chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epoetin Beta | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Epoetin Beta
- description
- Anemic breast cancer participants will receive epoetin beta treatment for 12 weeks.
- interventionNames
- Drug: Epoetin Beta
Primary outcomes (1)
- measure
- Percentage of Participants With Response to Treatment Based on Hemoglobin Levels
- timeFrame
- Week 12
- description
- Response was defined as increase of hemoglobin levels by at least 2 grams per deciliter (g/dL) as compared to baseline or the achievement of hemoglobin level of 12 g/dL after 12 weeks of treatment in the absence of red blood cells transfusion.
Secondary outcomes (7)
- measure
- Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Hemoglobin Level at Baseline
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.