A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00121836|
Recruitment Status : Completed
First Posted : July 21, 2005
Results First Posted : March 4, 2011
Last Update Posted : April 27, 2011
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Capecitabine Drug: Bevacizumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||109 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
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
- Overall Survival [ Time Frame: approximately 505 days (Median Time to Death) ]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 ]
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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00121836
Show 57 Study Locations
|Study Director:||Clinical Trials||Hoffmann-La Roche|