Trial information
A Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Breast Cancer Undergoing Chemotherapy
Status: Completed
Protocol number: ML17503
Sponsor: Roche S.p.a.
Company division: Pharmaceutical
Official Scientific Title: An open-label study of NeoRecormon on hemoglobin level/correction in patients with anemia and breast cancer receiving chemotherapy
Brief summary: This study will evaluate the efficacy and safety of subcutaneous NeoRecormon in anemic patients with breast cancer undergoing chemotherapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 200.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: epoetin beta[NeoRecormon]
Primary outcome: 1. Response rate after 12 weeks of therapy (percentage of patients with increase in hemoglobin of >=2g/dL)
Key secondary outcomes: 1. Efficacy: Mean change in hemoglobin levels after 12 weeks; % of patients with an increase of hemoglobin of >=1 g/dL after 4 weeks; mean time needed to increase hemoglobin level by >=1 g/dL; QOL after 12 weeks; Safety: adverse events related to study drug
Inclusion criteria:
- women >18 years of age;
- breast cancer;
- any type of chemotherapy planned for >=9 weeks;
- anemia.
Exclusion criteria:
- iron-deficiency anemia;
- thalassemia syndrome;
- blood transfusion or treatment with any erythropoietic agent within 4 weeks before 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: 08/29/2005
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Italy
- Arezzo
- Ascoli Piceno
- Busto Arsizio
- Catanzaro
- Cuneo
- Fano
- Firenze
- Frosinone
- Genova
- Macerata
- Messina
- Monza
- Napoli
- Pavia
- Pisa
- Pordenone
- Roma
- Vecchiazzano
- Vittorio Veneto
