Overview

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