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. Identifier: NCT00121836
Recruitment Status : Completed
First Posted : July 21, 2005
Results First Posted : March 4, 2011
Last Update Posted : April 27, 2011
Information provided by:
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Capecitabine Drug: Bevacizumab Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00121836

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Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Additional Information:
Responsible Party: Disclosures Group, Hoffmann-La Roche Identifier: NCT00121836     History of Changes
Other Study ID Numbers: ML18527
First Posted: July 21, 2005    Key Record Dates
Results First Posted: March 4, 2011
Last Update Posted: April 27, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action