Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: January 25, 2013
Last updated: December 23, 2014
Last verified: December 2014

This multicenter observational study will evaluate the efficacy and safety of Xe loda (capecitabine) in combination with docetaxel in first-line therapy in patie nts with HER2-negative metastatic breast cancer. Patients will be followed for a pproximately 6 months of treatment.

Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Program for Assessment of Capecitabine (Xeloda) Plus Docetaxel First-line Therapies in HER2-negative Metastatic Breast Cancer (XEBRA Study)

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 47
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with HER2-negative metastatic breast cancer initiated on first-line therapy with Xeloda in combination with docetaxel


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01777945

Budapest, Hungary, 1125
Budapest, Hungary, 1067
Budapest, Hungary, 1145
Budapest, Hungary, 1122
Debrecen, Hungary, 4032
Gyula, Hungary, 5700
Kaposvár, Hungary, 7400
Kecskemet, Hungary, 6000
Miskolc, Hungary, 3501
Nyíregyháza, Hungary, 4400
Szeged, Hungary, 6720
Szombathely, Hungary, 9700
Veszprem, Hungary, 8200
Zalaegerszeg, Hungary, 8900
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01777945     History of Changes
Other Study ID Numbers: ML28505
Study First Received: January 25, 2013
Last Updated: December 23, 2014
Health Authority: Hungary: National Institute of Pharmacy processed this record on March 03, 2015