Trial information
A Study to Assess Xeloda (Capecitabine) in Patients With Locally Advanced or Metastatic Breast Cancer
Status: Recruiting
Protocol number: NO16853
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of different dosing regimens of Xeloda in combination with Taxotere on disease progression in patients with locally advanced and/or metastatic breast cancer
Brief summary: This 2 arm study will compare the efficacy and safety of label dose Xeloda to that of a lower dose of Xeloda plus Taxotere in patients with locally advanced or metastatic breast cancer after failure of chemotherapy with an anthracycline.Patients will be randomized to receive either 1250mg/m2 or 825mg/m2 po bid on days 1-14 of each 3 week cycle, in combination with Taxotere 75mg/m2 iv on day 1 of each 3 week cycle. The anticipated time on study treatment is until disease progression and the target sample size is 100-500 individuals.
Target sample size is
440.
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. Time to disease progression or death Time frame: Event driven
Key secondary outcomes: 1. Overall response, time to response, duration of overall response, time to treatment failure, overall survival. Time frame: Event driven
2. AEs, laboratory parameters, vital signs, premature withdrawals, planned vs received dose. Time frame: Throughout study
Inclusion criteria:
- women >=18 years of age;
- >=1 target lesion;
- locally advanced or metastatic breast cancer;
- demonstrated resistance to anthracycline;
- >=2 regimens of chemotherapy for advanced/metastatic disease.
Exclusion criteria:
- previous treatment with Xeloda, continuous 5-fluorouracil infusion, or other oral fluoropyrimidines;
- previous treatment with paclitaxel or docetaxel for advanced/metastatic disease.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: July, 2003
Trial registration date: 06/24/2005
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Bosnia and Herzegovina
China
- Beijing
- Bengbu
- Dalian
- Hangzhou
- Shanghai
- Tianjin
India
- Ahmedabad
- Bangalore
- Cochin
- Hyderabad
- Jaipur
- Kolkata
- Ludhiana
- Manipal
- Mumbai
- New Delhi
- Trivandrum
- Vellore
Poland
Russian Federation
- Chelyabinsk
- Ivanovo
- Kazan
- Moscow
- Omsk
- Ryazan
- Samara
- St Petersburg
- Yaroslavl
South Africa
- Bloemfontein
- Durban
- Polokwane
Thailand
- Bangkok
- Chiang Mai
- Khon Kaen
United States
- Tucson , AZ
- Port St Lucie, FL
- Beech Grove, IN
- Overland Park, KS
- Baltimore, MD
- Frederick, MD
- Rockville, MD
- Summit, NJ
- Charleston, SC
- Houston, TX
- Abingdon, VA
