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

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ClinicalTrials.gov Identifier: NCT01777945
Recruitment Status : Completed
First Posted : January 29, 2013
Results First Posted : August 19, 2016
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date January 25, 2013
First Posted Date January 29, 2013
Results First Submitted Date April 12, 2016
Results First Posted Date August 19, 2016
Last Update Posted Date August 19, 2016
Study Start Date December 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 12, 2016)
Progression-free Survival (PFS) [ Time Frame: approximately 2 years ]
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.
Original Primary Outcome Measures
 (submitted: January 25, 2013)
Progression-free survival, defined as time from enrollment until disease progression or death of any cause [ Time Frame: approximately 3 years ]
Change History Complete list of historical versions of study NCT01777945 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 12, 2016)
  • Time to Treatment Failure [ Time Frame: approximately 2 years ]
    The time from enrollment to discontinuation of any drug of the treatment combination.
  • Overall Response Rate [ Time Frame: approximately 2 years ]
    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 ]
    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 ]
  • Percentage of Capecitabine Dose Modifications [ Time Frame: approximately 2 years ]
  • Number of Participants With Adverse Events [ Time Frame: approximately 2 years ]
Original Secondary Outcome Measures
 (submitted: January 25, 2013)
  • Time to treatment failure, defined as time from enrollment to discontinuation of any drug of the treatment combination [ Time Frame: approximately 3 years ]
  • Overall Response Rate [ Time Frame: approximately 3 years ]
  • Clinical Benefit Rate [ Time Frame: approximately 3 years ]
  • Duration of Treatment With Xeloda [ Time Frame: approximately 3 years ]
  • Rate of Xeloda dose modifications [ Time Frame: approximately 3 years ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title XEBRA Study: An Observational Study of Xeloda (Capecitabine) in Combination With Docetaxel in First Line in Participants With HER2-Negative Metastatic Breast Cancer
Official Title Program for Assessment of Capecitabine (Xeloda) Plus Docetaxel First-line Therapies in HER2-negative Metastatic Breast Cancer (XEBRA Study)
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Participants with HER2-negative metastatic breast cancer initiated on first-line therapy with Xeloda in combination with docetaxel
Condition Breast Cancer
Intervention
  • Drug: capecitabine
    Participants received capecitabine according to individualized physician-prescribed regimen.
  • Drug: docetaxel
    Participants received docetaxel according to individualized physician-prescribed regimens.
Study Groups/Cohorts Participants Receiving Capecitabine/Docetaxel
Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
Interventions:
  • Drug: capecitabine
  • Drug: docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 9, 2015)
46
Original Estimated Enrollment
 (submitted: January 25, 2013)
200
Actual Study Completion Date December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Hungary
Removed Location Countries  
 
Administrative Information
NCT Number NCT01777945
Other Study ID Numbers ML28505
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor Hoffmann-La Roche
Collaborators Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date February 2016