Trial information
(BRAVE Study) - A Study of NeoRecormon (Epoetin Beta) in Patients With Metastatic Breast Cancer
Status: Completed
Protocol number: BA16756
Sponsor: Hoffman-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of NeoRecormon on overall survival in patients with metastatic breast cancer.
Brief summary: This study will compare the outcome of treatment with or without NeoRecormon in patients with metastatic 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
460.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: epoetin beta[NeoRecormon]
Primary outcome: 1. Efficacy: Overall survival
Key secondary outcomes: 1. Efficacy: Serial tumor measurements, serial Hb determinations, documentation of transfusion, chemotherapy dose and dose adjustments. Safety: Adverse events, lab tests, C-reactive protein, iron parameters, blood pressure.
Inclusion criteria:
- women >=18 years of age;
- metastatic breast cancer;
- scheduled to begin either anthracycline- and/or taxane-based chemotherapy.
Exclusion criteria:
- women who are pregnant, lactating, or unwilling to use a reliable contraceptive method;
- treatment with epoetin or other erythropoietic substance in 2 months before study;
- patients who have participated in the active phase of another investigational drug study in the 4 weeks prior to screening, or are scheduled to participate in the active phase of another investigational drug study during the treatment period.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 05/23/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Austria
Belgium
- Aalst
- Leuven
- Namur
- Wilrijk
Brazil
- Belo Horizonte
- Jaú
- Porto Alegre
Denmark
France
- Bayonne
- Brest
- Colmar
- Grenoble
- Limoges
- Mulhouse
- Pierre Benite
Germany
- Düsseldorf
- Freiburg
- Hamburg
- Lemgo
- Oldenburg
- Trier
Greece
- Athens
- Hania
- Thessaloniki
Hungary
Italy
- Bergamo
- Biella
- Palermo
- Potenza
- Ragusa
- Ravenna
- Reggio Emilia
- Rozzano
- Sassari
- Thiene
- Torino
- Treviglio
- Udine
Mexico
- Chihuahua
- Mexico City
- Tijuana
Netherlands
Poland
- Lublin
- Olsztyn
- Poznan
- Wroclaw
Spain
- Barcelona
- Girona
- Oviedo
- Valencia
- Zaragoza
Switzerland
Taiwan
- Kaohsiung
- Taichung
- Tainan
Thailand
United Kingdom
- Belfast
- Cardiff
- Chelsmford
- Exeter
- Ipswich
- Leeds
- Leicester
- London
- Manchester
- Newcastle upon Tyne
- Nottingham
- Stoke-on-Trent
- Swansea
