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

Study Overview
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Brief Summary
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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.

Official Title
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Program for Assessment of Capecitabine (Xeloda) Plus Docetaxel First-line Therapies in HER2-negative Metastatic Breast Cancer (XEBRA Study)

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: capecitabine
* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants Receiving Capecitabine/Docetaxel<br>Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens. | Drug: capecitabine<br>* Participants received capecitabine according to individualized physician-prescribed regimen.<br>Drug: docetaxel<br>* Participants received docetaxel according to individualized physician-prescribed regimens.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) | 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. | approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Treatment Failure | The time from enrollment to discontinuation of any drug of the treatment combination. | approximately 2 years | 
| Overall Response Rate | The percentage of participants with complete or partial remission, based on evaluation of tumor responses assessed at regular examinations per routine clinical practice. | approximately 2 years | 
| Clinical Benefit Rate | The percentage of participants with an overall response (complete or partial remission) or with stable disease. | approximately 2 years | 
| Duration of Treatment With Xeloda |  | approximately 2 years | 
| Percentage of Capecitabine Dose Modifications |  | approximately 2 years | 
| Number of Participants With Adverse Events |  | approximately 2 years |