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A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00121836
First received: July 18, 2005
Last updated: April 25, 2011
Last verified: April 2011
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
 Drug: Capecitabine
Drug: Bevacizumab
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: approximately 505 days (Median Time to Death) ] [ Designated as safety issue: No ]
    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:
  • Number of Subjects With Adverse Events [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 109
Study Start Date: June 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121836

  Show 57 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Additional Information:
Clinical Study Report Synopsis  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00121836     History of Changes
Other Study ID Numbers: ML18527
Study First Received: July 18, 2005
Results First Received: December 16, 2009
Last Updated: April 25, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013