Trial information
A Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Metastatic Breast Cancer
Status: Completed
Protocol number: ML18028
Sponsor: Roche d.o.o.
Company division: Pharmaceutical
Official Scientific Title: An open-label study to investigate the safety of NeoRecormon therapy in adult anemic patients with metastatic breast cancer
Brief summary: This study will evaluate the safety of subcutaneous NeoRecormon in patients with anemia and metastatic breast cancer. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals. Target sample size is
13.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety study
Condition: Anemia
Intervention type: Drug
Intervention name: epoetin beta[NeoRecormon]
Primary outcome: 1. Safety: Adverse event rate and profile
Key secondary outcomes: 1. Efficacy: Hemoglobin response rate index
Inclusion criteria:
- adult patients >=18 years of age;
- metastatic breast cancer;
- anemia.
Exclusion criteria:
- transfusion of red blood cells within 2 months of study;
- poorly-controlled hypertension;
- relevant acute or chronic bleeding (requiring treatment) within 3 months of study;
- women who are pregnant or breastfeeding.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 10/28/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Slovenia
