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Trial information
A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer
Status: No longer recruiting
Protocol number: ML18527
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label study of Xeloda plus Avastin at time of disease progression in treatment-naïve women with HER2-negative metastatic breast cancer
Brief summary: This single arm study will evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin as first line treatment in women with metastatic breast cancer. Patients will receive Xeloda 1000mg/m2 po bid on days 1-15, and Avastin 15mg 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 individuals.
Target sample size is 92.
Study phase: IV
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 first disease progression or death Time frame: Event driven
Key secondary outcomes: 1. Overall response rate, time to response, response duration, time to treatment failure, duration of disease stabilization, overall survival. Time frame: Event driven
2. AEs, laboratory parameters, vital signs, premature withdrawals Time frame: Throughout study
Inclusion criteria: - women >=18 years of age;
- HER2-negative metastatic breast cancer;
- previous adjuvant chemotherapy or hormonal treatment;
- >=1 measurable target lesion.
Exclusion criteria: - previous treatment with chemotherapy, an anti-angiogenic agent, or a biologic therapy for advanced or metastatic cancer;
- radiation therapy within 4 weeks of study treatment start or insufficient recovery from the effects of prior radiation therapy;
- central nervous system metastases;
- other malignancy within last 5 years, except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix;
- serious concurrent infection.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: April, 2005
Trial registration date: 08/31/2005
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:United States - Birmingham, AL
- Los Angeles, CA
- San Diego , CA
- Farmington, CT
- Bonita Springs, FL
- Boynton Beach, FL
- Bradenton, FL
- Cape Coral, FL
- Fort Myers, FL
- Naples, FL
- Port Charlotte, FL
- Sarasota , FL
- Venice, FL
- Atlanta, GA
- Augusta, GA
- Tucker, GA
- Chicago, IL
- Indianapolis , IN
- Scarborough, ME
- Lansing, MI
- Kansas City, MO
- Lincoln, NE
- Las Vegas, NV
- Neptune, NJ
- Red Bank, NJ
- Rochester, NY
- Hickory , NC
- Beaufort, SC
- Charleston, SC
- Florence, SC
- Sumter, SC
- Milwaukee, WI
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