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

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 Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Capecitabine; Drug: Bevacizumab

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
    • Birmingham, Alabama, United States, 35235
    • Birmingham, Alabama, United States, 35205
    • Birmingham, Alabama, United States, 35211
    • Birmingham, Alabama, United States, 35213
    • Birmingham, Alabama, United States, 35022
  • California
    • Burbank, California, United States, 91505
    • Glendale, California, United States, 91206
    • Glendale, California, United States, 91204
    • Los Angeles, California, United States, 90057
    • San Diego, California, United States, 92121
  • Connecticut
    • Farmington, Connecticut, United States, 06030
  • Florida
    • Bonita Springs, Florida, United States, 34135
    • Boynton Beach, Florida, United States, 33435
    • Bradenton, Florida, United States, 34209
    • Cape Coral, Florida, United States, 33990
    • Fort Myers, Florida, United States, 33901
    • Fort Myers, Florida, United States, 33908
    • Naples, Florida, United States, 34102
    • Naples, Florida, United States, 34119
    • Port Charlotte, Florida, United States, 33980
    • Sarasota, Florida, United States, 34232
    • Sarasota, Florida, United States, 34236
    • Venice, Florida, United States, 34292
  • Georgia
    • Atlanta, Georgia, United States, 30341
    • Augusta, Georgia, United States, 30901
    • Tucker, Georgia, United States, 30084
  • Illinois
    • Chicago, Illinois, United States, 60611
  • Indiana
    • Indianapolis, Indiana, United States, 46202
    • Indianapolis, Indiana, United States, 46219
  • Iowa
    • Waterloo, Iowa, United States, 50702
  • Maine
    • Scarborough, Maine, United States, 04074
  • Maryland
    • Prince Frederick, Maryland, United States, 20678
  • Michigan
    • Lansing, Michigan, United States, 48909
  • Missouri
    • Kansas City, Missouri, United States, 64111
    • Kansas City, Missouri, United States, 64131
    • Kansas City, Missouri, United States, 64154
    • Kansas City, Missouri, United States, 64064
    • Kansas City, Missouri, United States, 66112
    • Kansas City, Missouri, United States, 66210
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
    • Omaha, Nebraska, United States, 68114
  • Nevada
    • Las Vegas, Nevada, United States, 89106
  • New Jersey
    • Brick, New Jersey, United States, 08724
    • Neptune, New Jersey, United States, 07754
    • Red Bank, New Jersey, United States, 07701
  • New York
    • Rochester, New York, United States, 14642
  • North Carolina
    • Hickory, North Carolina, United States, 28602
  • Ohio
    • Canton, Ohio, United States, 44718
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
  • South Carolina
    • Beaufort, South Carolina, United States, 29902
    • Charleston, South Carolina, United States, 29406
    • Florence, South Carolina, United States, 29506
    • Hilton Head Island, South Carolina, United States, 29926
    • Sumter, South Carolina, United States, 29150
  • Virginia
    • Abingdon, Virginia, United States, 24211
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Capecitabine; 1000 mg/m² PO BID on Days 1-15 of each 3-week cycle; Other Names: Xeloda; Drug: Bevacizumab; 15 mg IV on Day 1 of each 3-week cycle; Other Names: Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Adverse Events	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.	Throughout study
Premature Withdrawal From Study Due to Adverse Events	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.	Throughout study
Number of Participants With Marked Laboratory Abnormalities	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.	until progressive disease or for up to 3 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

Helpful Links

• Clinical Study Report Synopsis

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: July 18, 2005
• First Submitted That Met QC Criteria: July 18, 2005
• First Posted (Estimate): July 21, 2005

Study Record Updates

• Last Update Posted (Estimate): April 27, 2011
• Last Update Submitted That Met QC Criteria: April 25, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Capecitabine; Bevacizumab
• Other Study ID Numbers: ML18527