Trial information
A Study of Xeloda (Capecitabine) Prior to Surgery in Women With Breast Cancer
Status: No longer recruiting
Protocol number: ML16986
Sponsor: Roche SAS
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of Xeloda or intravenous 5-fluorouracil, both in combination with epirubicin and cyclophosphamide, on complete histological tumor response in patients with breast cancer before surgery
Brief summary: This study will evaluate the efficacy and safety of treatment with oral Xeloda or intravenous 5-fluorouracil, in combination with epirubicin and cyclophosphamide, prior to surgery in patients with breast cancer. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Target sample size is
182.
Study phase: II
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Breast Cancer
Intervention type: Drug
Intervention name: capecitabine[Xeloda]
Primary outcome: 1. Efficacy: Complete histologic tumor response after definitive surgery
Key secondary outcomes: 1. Efficacy:Breast conservation, objective tumor response, and progression-free survival and overall survival at 5 years Safety: Clinical adverse events and laboratory parameters
Inclusion criteria:
- women 18-70 years of age;
- unilateral, non-metastatic, operable, breast cancer;
- measurable lesion.
Exclusion criteria:
- previous radiotherapy, chemotherapy, or hormonal therapy for breast cancer;
- history of a malignancy during the last 5 years other than cutaneous basal cell cancer or in situ cancer of the uterine cervix;
- serious concomitant infection.
Gender: Females
Age limits: Min: 18 Years Max: 70 Years
Accepts healthy volunteers: No
Anticipated start date: March, 2004
Trial registration date: 08/31/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
France
- Bayonne
- Bourg En Bresse
- Colmar
- Dijon
- Grenoble
- Limoges
- Montbeliard
- Montfermeil
- Nice
- Paris
- Saint Herblain
- Strasbourg
- Toulouse
