Phase 2
Completed N=200
A Study to Evaluate Efficacy and Safety of Epoetin Beta (NeoRecormon®) in Anemic Participants With Breast Cancer Undergoing Chemotherapy
Source: ClinicalTrials.gov NCT02761642 ↗Enrolled (actual)
200
Serious AEs
8.6%
Results posted
Aug 2018
Primary outcomePrimary: Percentage of Participants With Response to Treatment Based on Hemoglobin Levels — 46.2 percentage of participants
Summary
This study will evaluate the efficacy and safety of subcutaneous (SC) epoetin beta in anemic participants with breast cancer undergoing chemotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Response to Treatment Based on Hemoglobin Levels |
46.2 | — |
| SECONDARY Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Hemoglobin Level at Baseline |
9.4; 10.5; 2.1; 1.1 | — |
| SECONDARY Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to Chemotherapy at Baseline |
10.2; 9.8; 10.2; 1.7; 1.6; 1.2 | — |
| SECONDARY Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Time Spent on Chemotherapy at Baseline |
10.0; 10.0; 1.6; 1.4 | — |
| SECONDARY Overall Mean Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment |
10.0; 1.6 | — |
| SECONDARY Percentage of Participants With an Increase From Baseline in Hemoglobin Levels of At Least 1 g/dL After 4 Weeks |
45.4 | — |
| SECONDARY Mean Time Needed to Increase Hemoglobin Level by At Least 1 g/dL |
34.2 | — |
| SECONDARY Quality of Life Assessment Using Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Scores |
65.6; 71.9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02761642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.