Trial information
A Study of Xeloda (Capecitabine) in Patients With Advanced Breast Cancer
Status: Completed
Protocol number: ML16505
Sponsor: Roche S.p.A. Italy
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the addition of oral Xeloda to intravenous Taxotere and epirubicin on progression-free survival in patients with advanced breast cancer
Brief summary: This study will evaluate the efficacy and safety of oral Xeloda plus intravenousTaxotere and epirubicin, compared with the combination therapy alone. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Target sample size is
340.
Study phase: III
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
Condition: Breast Cancer
Intervention type: Drug
Intervention name: capecitabine[Xeloda]
Primary outcome: 1. Progression-free survival and overall survival
Key secondary outcomes: 1. Efficacy:Complete remission, partial remission, stable disease, progressive disease and overall survival. Safety: Adverse events and laboratory parameters
Inclusion criteria:
- women 18-70 years of age;
- locally advanced or metastatic breast cancer (stage III or IV);
- >=1 measurable lesion.
Exclusion criteria:
- prior chemotherapy for metastatic disease;
- clinically significant cardiac disease;
- history of cancer, other than non-melanoma skin cancer or cancer in situ of the cervix.
Gender: Females
Age limits: Min: 18 Years Max: 70 Years
Accepts healthy volunteers: No
Trial registration date: 10/27/2005
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Italy
- Antella (Fi)
- Bari
- Bergamo
- Bologna
- Cagliari
- Cosenza
- Cuneo
- Fano
- Frattamaggiore
- Genova
- Livorno
- Mantova
- Perugia
- Potenza
- Reggio Calabria
- Reggio Emilia
- Sassari
- Terni
- Torino
- Trento
- Trieste
- Udine
