XEBRA Study: An Observational Study of Xeloda (Capecitabine) in Combination With Docetaxel in First Line in Patients With HER2-Negative Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01777945
First received: January 25, 2013
Last updated: February 1, 2016
Last verified: February 2016

January 25, 2013
February 1, 2016
December 2012
December 2014   (final data collection date for primary outcome measure)
Progression-free survival, defined as time from enrollment until disease progression or death of any cause [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01777945 on ClinicalTrials.gov Archive Site
  • Time to treatment failure, defined as time from enrollment to discontinuation of any drug of the treatment combination [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Overall response rate [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Clinical benefit rate [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Duration of treatment with Xeloda [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Rate of Xeloda dose modifications [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
Same as current
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XEBRA Study: An Observational Study of Xeloda (Capecitabine) in Combination With Docetaxel in First Line in Patients With HER2-Negative Metastatic Breast Cancer
Program for Assessment of Capecitabine (Xeloda) Plus Docetaxel First-line Therapies in HER2-negative Metastatic Breast Cancer (XEBRA Study)
This multicenter observational study will evaluate the efficacy and safety of Xeloda (capecitabine) in combination with docetaxel in first-line therapy in patients with HER2-negative metastatic breast cancer. Patients will be followed for approximately 6 months of treatment.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Patients with HER2-negative metastatic breast cancer initiated on first-line therapy with Xeloda in combination with docetaxel
Breast Cancer
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • HER2-negative metastatic breast cancer
  • Patients initiated on first-line therapy with Xeloda and docetaxel in accordance with the Summary of Product Characteristics; patients who started treatment with Xeloda and docetaxel no more than 3 months before enrollment in this study are also eligible

Exclusion Criteria:

  • Contraindications to Xeloda treatment according to the Summary of Product Characteristics
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Hungary
 
NCT01777945
ML28505
Not Provided
Not Provided
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Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP