Clinical trial NCT00121836: A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2005-07-21
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival
timeFrame: approximately 505 days (Median Time to Death)
Secondary outcomes:
measure: Number of Subjects With Adverse Events
timeFrame: Throughout study
measure: Premature Withdrawal From Study Due to Adverse Events
timeFrame: Throughout study
measure: Number of Participants With Marked Laboratory Abnormalities
timeFrame: until progressive disease or for up to 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Burbank
country: United States
state: California
city: Glendale
country: United States
state: California
city: Glendale
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Farmington
country: United States
state: Connecticut
city: Bonita Springs
country: United States
state: Florida
city: Boynton Beach
country: United States
state: Florida
city: Bradenton
country: United States
state: Florida
city: Cape Coral
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Port Charlotte
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Venice
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Tucker
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Waterloo
country: United States
state: Iowa
city: Scarborough
country: United States
state: Maine
city: Prince Frederick
country: United States
state: Maryland
city: Lansing
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Brick
country: United States
state: New Jersey
city: Neptune
country: United States
state: New Jersey
city: Red Bank
country: United States
state: New Jersey
city: Rochester
country: United States
state: New York
city: Hickory
country: United States
state: North Carolina
city: Canton
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Beaufort
country: United States
state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: Florence
country: United States
state: South Carolina
city: Hilton Head Island
country: United States
state: South Carolina
city: Sumter
country: United States
state: South Carolina
city: Abingdon
country: United States
state: Virginia
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: