A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer
An Open-label Study of Xeloda Plus Avastin at Time of Disease Progression in Treatment-naïve Women With HER2-negative Metastatic Breast Cancer
1 other identifier
interventional
109
1 country
57
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 breast-cancer
Started Jun 2005
Typical duration for phase_4 breast-cancer
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 18, 2005
CompletedFirst Posted
Study publicly available on registry
July 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
March 4, 2011
CompletedApril 27, 2011
April 1, 2011
3.5 years
July 18, 2005
December 16, 2009
April 25, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
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
approximately 505 days (Median Time to Death)
Secondary Outcomes (3)
Number of Subjects With Adverse Events
Throughout study
Premature Withdrawal From Study Due to Adverse Events
Throughout study
Number of Participants With Marked Laboratory Abnormalities
until progressive disease or for up to 3 years
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Women \>=18 years of age
- HER2-negative metastatic breast cancer
- Previous adjuvant chemotherapy or hormonal treatment
- \>=1 measurable target lesion
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (57)
Unknown Facility
Birmingham, Alabama, 35022, United States
Unknown Facility
Birmingham, Alabama, 35205, United States
Unknown Facility
Birmingham, Alabama, 35209, United States
Unknown Facility
Birmingham, Alabama, 35211, United States
Unknown Facility
Birmingham, Alabama, 35213, United States
Unknown Facility
Birmingham, Alabama, 35235, United States
Unknown Facility
Burbank, California, 91505, United States
Unknown Facility
Glendale, California, 91204, United States
Unknown Facility
Glendale, California, 91206, United States
Unknown Facility
Los Angeles, California, 90057, United States
Unknown Facility
San Diego, California, 92121, United States
Unknown Facility
Farmington, Connecticut, 06030, United States
Unknown Facility
Bonita Springs, Florida, 34135, United States
Unknown Facility
Boynton Beach, Florida, 33435, United States
Unknown Facility
Bradenton, Florida, 34209, United States
Unknown Facility
Cape Coral, Florida, 33990, United States
Unknown Facility
Fort Myers, Florida, 33901, United States
Unknown Facility
Fort Myers, Florida, 33908, United States
Unknown Facility
Naples, Florida, 34102, United States
Unknown Facility
Naples, Florida, 34119, United States
Unknown Facility
Port Charlotte, Florida, 33980, United States
Unknown Facility
Sarasota, Florida, 34232, United States
Unknown Facility
Sarasota, Florida, 34236, United States
Unknown Facility
Venice, Florida, 34292, United States
Unknown Facility
Atlanta, Georgia, 30341, United States
Unknown Facility
Augusta, Georgia, 30901, United States
Unknown Facility
Tucker, Georgia, 30084, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Indianapolis, Indiana, 46202, United States
Unknown Facility
Indianapolis, Indiana, 46219, United States
Unknown Facility
Waterloo, Iowa, 50702, United States
Unknown Facility
Scarborough, Maine, 04074, United States
Unknown Facility
Prince Frederick, Maryland, 20678, United States
Unknown Facility
Lansing, Michigan, 48909, United States
Unknown Facility
Kansas City, Missouri, 64064, United States
Unknown Facility
Kansas City, Missouri, 64111, United States
Unknown Facility
Kansas City, Missouri, 64131, United States
Unknown Facility
Kansas City, Missouri, 64154, United States
Unknown Facility
Kansas City, Missouri, 66112, United States
Unknown Facility
Kansas City, Missouri, 66210, United States
Unknown Facility
Lincoln, Nebraska, 68510, United States
Unknown Facility
Omaha, Nebraska, 68114, United States
Unknown Facility
Las Vegas, Nevada, 89106, United States
Unknown Facility
Brick, New Jersey, 08724, United States
Unknown Facility
Neptune City, New Jersey, 07754, United States
Unknown Facility
Red Bank, New Jersey, 07701, United States
Unknown Facility
Rochester, New York, 14642, United States
Unknown Facility
Hickory, North Carolina, 28602, United States
Unknown Facility
Canton, Ohio, 44718, United States
Unknown Facility
Oklahoma City, Oklahoma, 73112, United States
Unknown Facility
Beaufort, South Carolina, 29902, United States
Unknown Facility
Charleston, South Carolina, 29406, United States
Unknown Facility
Florence, South Carolina, 29506, United States
Unknown Facility
Hilton Head Island, South Carolina, 29926, United States
Unknown Facility
Sumter, South Carolina, 29150, United States
Unknown Facility
Abingdon, Virginia, 24211, United States
Unknown Facility
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The primary endpoint TTP was changed to overall survival (OS) due to issues regarding tumor assessment data based on RECIST and poor response from investigators to related queries that developed after the planned interim analysis.
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 18, 2005
First Posted
July 21, 2005
Study Start
June 1, 2005
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
April 27, 2011
Results First Posted
March 4, 2011
Record last verified: 2011-04