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

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Capecitabine

Criteria

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