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