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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01725386 |
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Date of registration:
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08/11/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An Observational Study of Xeloda (Capecitabine) in Participants With Metastatic or Advanced Breast Cancer
XEPAD |
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Scientific title:
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Study on Xeloda® to Document Its Use in Routine Practice in Patients With Metastatic or Advanced Breast Cancer |
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Date of first enrolment:
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March 2011 |
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Target sample size:
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274 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01725386 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Drug: Capecitabine
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Primary Outcome(s)
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Percentage of Participants Receiving Concomitant Medications During the Study
[Time Frame: Up to approximately 4 years]
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Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy
[Time Frame: Up to approximately 4 years]
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Secondary Outcome(s)
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Percentage of Participants With Relevant Medical History Assessed at Baseline
[Time Frame: Day 1]
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Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline
[Time Frame: Day 1]
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Percentage of Participants With Adverse Events
[Time Frame: Up to approximately 4 years]
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Mean Survival Time
[Time Frame: Up to approximately 4 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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