A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer
This single-arm study was designed to evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin as first-line treatment in women with metastatic breast cancer. Patients received Xeloda 1000 mg/m² orally (PO) twice daily (BID) on Days 1-15, and Avastin 15 mg intravenously (IV) on Day 1 of each 3-week cycle. The anticipated time on study treatment was until disease progression or unacceptable toxicity. The target sample size was <100 individuals.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label Study of Xeloda Plus Avastin at Time of Disease Progression in Treatment-naïve Women With HER2-negative Metastatic Breast Cancer|
- Overall Survival [ Time Frame: approximately 505 days (Median Time to Death) ] [ Designated as safety issue: No ]Overall survival was defined as the time from date of first treatment dose (Day 1) to date of death, across the study phases regardless of the cause of death
- Number of Subjects With Adverse Events [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
The secondary outcome measure was to evaluate the safety profile, including a summary of adverse events (AEs) assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.
Intensity of AEs were graded according to NCI CTCAE version 3.0 on a 5-point scale: Grade 1=Mild Discomfort, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life Threatening/Disabling and Grade 5=Death. An SAE was defined as any experience that suggested a significant hazard,contraindication, side effect, or precaution.
- Premature Withdrawal From Study Due to Adverse Events [ Time Frame: Throughout study ] [ Designated as safety issue: No ]The secondary outcome measure was to evaluate the safety profile, including a summary of premature withdrawals due to adverse events occurring in more than 1 patient in either study group, by system organ class.
- Number of Participants With Marked Laboratory Abnormalities [ Time Frame: until progressive disease or for up to 3 years ] [ Designated as safety issue: No ]The secondary outcome measure was to evaluate the safety profile, including a summary of marked laboratory abnormalities in >= 5% of patients. n=number of participants with the laboratory measure,Number=number of participants with the abnormality. Laboratory values were flagged as Low(L) or High(H) if they were below the lower limit or above the upper limit of Roche standard reference range, respectively. Marked laboratory abnormalities (flagged as HH and LL) were defined as those values that were outside the Roche marked reference range and showed a clinically relevant change from baseline.
|Study Start Date:||June 2005|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
1000 mg/m² PO BID on Days 1-15 of each 3-week cycle
Other Name: XelodaDrug: Bevacizumab
15 mg IV on Day 1 of each 3-week cycle
Other Name: Avastin
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121836
Show 57 Study Locations
|Study Director:||Clinical Trials||Hoffmann-La Roche|