An Observational Study of Xeloda (Capecitabine) in Participants With Metastatic or Advanced Breast Cancer

Study Overview
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Brief Summary
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This observational study will evaluate the routine clinical use and the safety and efficacy of capecitabine (Xeloda®) in participants with metastatic or advanced breast cancer. Eligible participants will be followed for up to 24 months.

Official Title
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Study on Xeloda® to Document Its Use in Routine Practice in Patients With Metastatic or Advanced Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult female participants, >/= 18 years of age Cytologic/histopathologic confirmed diagnosis of metastatic breast cancer Prescribed capecitabine as in routine clinical practice Informed consent signed Exclusion Criteria: Participation in any other clinical trial History of severe and unexpected reactions to fluoropyrimidine therapy Hypersensitivity to capecitabine or to any of the excipients of fluorouracil Known dihydropyrimidine dehydrogenase (DPD) deficiency Pregnant or lactating women Severe leucopenia, neutropenia, or thrombocytopenia Severe hepatic impairment Severe renal impairment (creatinine clearance below 30 ml/min) Treatment with sorivudine or its chemically related analogues, such as brivudine Refusal to give consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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 |
| --- | --- |
| Monotherapy<br>Capecitabine as monotherapy according to prescribing information and normal clinical practice. | Drug: Capecitabine<br>* Oral tablet(s) administered according to prescribing information<br>* Other names: XELODA;|
| Combination Therapy<br>Capecitabine as part of combination therapy according to prescribing information and normal clinical practice. | Drug: Capecitabine<br>* Oral tablet(s) administered according to prescribing information<br>* Other names: XELODA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy | To document use of Capecitabine regimen in the management of participants with metastatic breast cancer, the choice of Capecitabine monotherapy versus combination therapy was summarized according to whether the selection was for the participant's first, second, or third line of treatment. | Up to approximately 4 years | 
| Percentage of Participants Receiving Concomitant Medications During the Study | Percentage of participants receiving concomitant medications during the study along with their prescribed monotherapy or combination therapy were reported. | Up to approximately 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Relevant Medical History Assessed at Baseline | To document the metastatic breast cancer participant profile, the percentage of participants with relevant medical history as assessed at baseline was summarized. | Day 1 | 
| Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline | To document the metastatic breast cancer participant profile, the percentage of participants with histopathology grade diagnosis of moderately differentiated, well differentiated, poorly differentiated/undifferentiated as assessed at baseline was summarized. | Day 1 | 
| Mean Survival Time |  | Up to approximately 4 years | 
| Percentage of Participants With Adverse Events |  | Up to approximately 4 years |