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
|Condition or disease||Intervention/treatment|
|Breast Cancer||Drug: capecitabine Drug: docetaxel|
|Study Type :||Observational|
|Actual Enrollment :||46 participants|
|Official Title:||Program for Assessment of Capecitabine (Xeloda) Plus Docetaxel First-line Therapies in HER2-negative Metastatic Breast Cancer (XEBRA Study)|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Participants Receiving Capecitabine/Docetaxel
Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
Participants received capecitabine according to individualized physician-prescribed regimen.
Participants received docetaxel according to individualized physician-prescribed regimens.
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777945
|Budapest, Hungary, 1067|
|Budapest, Hungary, 1122|
|Budapest, Hungary, 1125|
|Budapest, Hungary, 1145|
|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|
|Study Director:||Clinical Trials||Hoffmann-La Roche|