Trial information
A Study of Xeloda (Capecitabine) in Patients With Metastatic or Locally Advanced Breast Cancer
Status: No longer recruiting
Protocol number: M66112
Sponsor: Roche SAS
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the effect of Xeloda on time to disease progression in patients with metastatic or locally advanced breast cancer previously treated with an anthracycline and a taxane
Brief summary: This study will evaluate the efficacy and safety of oral Xeloda in patients previously treated for metastatic or locally advanced breast cancer with an anthracycline and a taxane. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Target sample size is 120.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Breast Cancer
Intervention type: Drug
Intervention name: capecitabine[Xeloda]
Primary outcome: 1. Time to progression
Key secondary outcomes: 1. Efficacy: Objective response rate (complete response plus partial response), duration of response, overall survival. Safety:adverse events, laboratory tests. Quality of life: EORTC QLQ C30 questionnaire
Inclusion criteria:
- women >=18 years of age;
- metastatic or locally advanced breast cancer;
- previous receipt of 2 or 3 lines of chemotherapy;
- previous receipt of an anthracycline (eg, doxorubicin, epirubicin) and a taxane (eg, paclitaxel, docetaxel);
- >=1 measurable or evaluable lesion.
Exclusion criteria:
- brain metastasis;
- previous history of a malignancy during the last 5 years other than cutaneous basal cell cancer or cancer in situ of the uterine cervix;
- serious concomitant infection.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: March, 1999
Trial registration date: 08/31/2005
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
France
- Avignon
- Bobigny
- Bourg En Bresse
- Clermont-Ferrand
- Colmar
- Le Mans
- Mainvilliers
- Metz
- Montpellier
- Nice
- Paris
- Pierre Benite
- Rennes
- Saint Herblain
- Strasbourg
- Vannes
