XEBRA Study: An Observational Study of Xeloda (Capecitabine) in Combination With Docetaxel in First Line in Participants 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: July 12, 2016
Last verified: February 2016

January 25, 2013
July 12, 2016
December 2012
December 2014   (final data collection date for primary outcome measure)
Progression-free Survival (PFS) [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
The time from enrollment until disease progression, assessed as the time to tumor progression, as evaluated by regular examinations per routine clinical practice, or death from any cause.
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 ]
Complete list of historical versions of study NCT01777945 on ClinicalTrials.gov Archive Site
  • Time to Treatment Failure [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
    The time from enrollment to discontinuation of any drug of the treatment combination.
  • Overall Response Rate [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
    The percentage of participants with complete or partial remission, based on evaluation of tumor responses assessed at regular examinations per routine clinical practice.
  • Clinical Benefit Rate [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
    The percentage of participants with an overall response (complete or partial remission) or with stable disease.
  • Duration of Treatment With Xeloda [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Percentage of Capecitabine Dose Modifications [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Number of Participants With Adverse Events [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
XEBRA Study: An Observational Study of Xeloda (Capecitabine) in Combination With Docetaxel in First Line in Participants 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 participants with HER2-negative metastatic breast cancer. Participants will be followed for approximately 6 months of treatment.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Participants with HER2-negative metastatic breast cancer initiated on first-line therapy with Xeloda in combination with docetaxel
Breast Cancer
  • Drug: capecitabine
    Participants received capecitabine according to individualized physician-prescribed regimen.
  • Drug: docetaxel
    Participants received docetaxel according to individualized physician-prescribed regimens.
Participants Receiving Capecitabine/Docetaxel
Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
Interventions:
  • Drug: capecitabine
  • Drug: docetaxel
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 participants, >/= 18 years of age
  • HER2-negative metastatic breast cancer
  • Participants initiated on first-line therapy with Xeloda and docetaxel in accordance with the Summary of Product Characteristics; participants 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
No
Not Provided
Not Provided
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