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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

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01777945
First received: January 25, 2013
Last updated: May 23, 2013
Last verified: May 2013
History of Changes

January 25, 2013
May 23, 2013
January 2013
July 2015   (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
Not Provided
Not Provided
 
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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.
 
Recruiting
200
July 2015
July 2015   (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
No
Contact: Reference Study ID Number: ML28505 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
Hungary
 
NCT01777945
ML28505
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2013

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